Macular Degeneration Foundation

Pegcetacoplan Study Results


Press Release

WALTHAM, Mass., March 16, 2022 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc.
(Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan, an investigational, targeted C3 therapy, continued to reduce geographic atrophy (GA) lesion growth and demonstrate a favorable safety profile at month 18 for the treatment of GA secondary to age-related macular degeneration (AMD). These data will be included in the New Drug Application (NDA) that the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

“It is exciting to see these positive data with pegcetacoplan, which showed continuous and potentially improving effects over time. These 18-month results provide further evidence that pegcetacoplan meaningfully slows disease progression and has the potential to preserve vision longer,” said Jeffrey S. Heier, M.D., principal investigator of the DERBY study and director, retina service and director, retinal research, Ophthalmic Consultants of Boston. “In my practice, I have seen how devastating it can be for people living with GA to lose more of their vision year after year. There is an urgent unmet need in GA, and these results reinforce the potential of pegcetacoplan to become the first-ever treatment for patients with this debilitating disease.”

New “Wet” AMD Medication Delivery System

The FDA has approved Roche’s Susvimo (ranibizumab), a long-lasting injectable drug for treating people with “wet” age-related macular degeneration.

Susvimo, which continuously delivers therapy via a refillable ocular implant, can be administered just twice a year, providing an alternative to other injections that are often given monthly.

The drug’s approval was supported by phase 3 data demonstrating that patients treated with Susvimo experienced vision increases equivalent to those receiving monthly ranibizumab injections. Roche noted that 98 percent of patients were able to go six months before needing their first refill of Susvimo.

Additional Information

Roche News Release

Product Video and Important Safety Information

Chocolate!

In recent years at least two studies demonstrated the benefits of flavonoid-rich dark chocolate over milk chocolate as to improved vision. That was good news for chocolate lovers.

In a new double-blind randomized clinical trial (Department of Ophthalmology Ludwig-Maximilians-University, Munich, Germany), the short-term benefits of dark chocolate were once again put to the test.

Unfortunately, this time they saw no benefit to visual function of either dark or milk chocolate. Researchers admit sample size was small (22 participants) and further trials would be needed to rule in or out possible longterm benefits.

Conclusion: Chocolate tastes good!

Why We Should Learn About the Side Effects of Drugs

By Dan Roberts – MDSupport.org

“Tom”, a 73-year-old male, complained of severe dry eye syn- drome and loss of acuity after one injection of an anti-VEGF drug for treatment of wet macular degeneration. Tom had previously undergone four months of treatment with a similar drug, but his physician recommended changing to the newer and less expensive one.

Both drugs had been clinically-tested and FDA-approved for ophthalmic use. Dry eye syndrome was not reported in the trials as an adverse event for anti-VEGF drugs, so the physician did not suspect it to be related. Instead, he prescribed medication to treat Tom’s new symptom. Tom refused the medication, saying he felt that his condition may be an adverse event so rare that it was not reported in the trial results. He did not agree with his physician’s opinion that the benefits of the new drug outweighed the risk in this case, and he insisted that he be returned to the original treatment. After doing so, Tom’s condition improved, and his vision returned to baseline.

Agencies such as the FDA are responsible for approving drugs and for monitoring their safety after reaching the market. Timely and accurate reporting of side effects and serious adverse events (SAE’s) by pharmaceuticals and physicians is important, especially in the case of newly marketed drugs. Physicians are expected to report to the pharmaceutical companies, and the companies are expected to take appropriate action when necessary. The safety of the public depends upon compliance with reporting procedures. Unreported SAE’s, however, are still too common, and can lead to public health disasters. Physicians and pharmaceutical companies are obliged to comply with the reporting process, and patients play an important role as well. Every patient should be aware not only of the pre-market discovery of side effects and SAE’s of a particular drug, but of the potential for new and unexpected events.

Patients should be encouraged to report all physiological and psychological changes during treatment, whether or not such changes are reported in the trial results and discussed in the prescribing information. Such reports should be made to the physicians, but in the event that a report goes no further, patients need to have the opportunity to communicate directly with the drug companies and governing agencies, and to share information with one another.

An Internet site at http://www.eHealthMe.com is one solution. The site has an interactive database for use by patients to identify, track, and report their individual side effects and adverse events during drug therapy. The web-based application contains a searchable database of labeled side effects, SAE’s, and warnings for individual drugs on the market. Additionally, the application allows patients to anonymously enter information and communicate with one another about personal conditions not listed.

The newly-entered information is tabulated by drug, type and frequency, and the results are accessible to physicians, pharmaceutical companies, and governing agencies. The intention is that this complement to the reporting process might expedite discovery of new post-market side effects and SAE’s, allowing for more immediate and effective intervention when necessary. To make a report, go to http://www.eHealthMe.com

Life-Style Changes

Through a program of diet, sleep, exercise, and relaxation techniques, combined with supplemental probiotics and phytonutrients, a team of 3 international scientists have described a plan that may actually reverse aging and its resultant effect on disease.

In their study, the diet and lifestyle treatment group decreased in biological age by 3.23 years compared to the control group. The data also showed that those in the treatment group decreased in biological age by 1.96 years over the eight weeks.

Some of the important life-style changes:

  1. Include the most colorful fruits and veggies in your diet
  2. Include fiber and probiotics for “gut health”.
  3. Quit smoking.
  4. Sleep, exercise and relaxation techniques can lower
    blood pressure which, in turn, can lower a patient’s
    intraocular pressure

“Smart Phones – Getting Better”

Joe Fontenot MD
Patti Hacker Equipment Specialist
Community Services for Vision Rehabilitation

Smart phones are used by a majority, possibly more than 75 %, of the US population. There are literally thousands of “Apps” or Applications for the blind and visually impaired. More and more are multifunctional and many are free. For the blind and visually impaired, the smart phone is the best thing since Louis Braille’s tactile alphabet. It allows them to communicate effortlessly, do research and have a hand-held computer. More apps are being developed every day, and thousands are now available. Many are useful for the visually impaired, and some are specifically for them.

Image of IPhone

There are many different makes and varieties of smart phones, and some are simplified and advertised as designed for easy use by the visually impaired. At this time in 2021, the iPhone is the most popular in the US, including in the blind/visually impaired population. In some other countries, the Android may be more popular. Phone costs vary , and at this time in the US, the I Phone is usually a few hundred dollars more expensive than the Android models.

The iPhone
Since being introduced in 2007, the IPhone by Apple has been regarded by many as the best smart phone for the visually impaired. This is primarily because it has many built-in accessibility features, which simply need to be turned on in Settings such as “Voiceover” which will read the screen display, and “Zoom” and other magnification options.

Apps for the Visually Impaired
In addition to the inherent accessibility options in the IPhone and the Android, there are now a myriad of apps. These will magnify, contact help from a sighted volunteer, count money, recognize faces, etc. The variety and usefulness of apps has steadily and progressively improved, and there does not seem to be an end in sight.

As an example, we can look at apps for reading text. In 2007 a text reader app, the Kurzweil NFB reader app was introduced at a cost of $99. Subsequently the A few years later, another text reader app, Envision reader was available at $20. In 2020 the Apple Seeing A1, which in addition to reading text will count money, has a bar code scanner and identifies images was released and it is free for iPhone users.

This sort of increasing function and decreasing cost is typical of app development for the visually impaired, and we hope will continue.

All with vision loss should use smart phones to their maximum and will become more independent, functional and happy because they do so.

Summary
The smart phone is a communication and computing device of great help to all, especially for the visually impaired. It is rapidly improving, and more apps that are specifically for the visually impaired are becoming available almost weekly.

What Do I Do? … My Doctor just told me I have Macular Degeneration

Most people found to have AMD are:

  • Over the age of 55
  • Have noticed changes in their vision
  • Have gone to an ophthalmologist or optometrist who found evidence of macular degeneration in their eyes.

Dry AMD
Some of the initial changes to the eye caused by AMD are mild and do not require treatment. Your doctor will see small yellow areas of “drusen”, a German word for “bump”, in one or both eyes. This is known as “Dry Macular Degeneration”. Symptoms may include visual distortions, the need for more light when reading and a blurry or blind spot in your central field of vision. Side (peripheral) vision is not affected.

Images of wet and dry types of macular degeneration

Wet AMD
The “Wet” type of macular degeneration is characterized by the growth of abnormal blood vessels that leak fluid or blood into the macula (the area of the retina responsible for central vision). Symptoms of wet macular degeneration are the same as the dry form but usually appear suddenly and get worse rapidly.

What to Do!
Ask your eye doctor if you should see an ophthalmologist who specializes in the treatment of macular degeneration or a retina specialist. Retina specialists are best qualified to decide if active treatment is needed and when to begin therapy.

Image of injection of anti-VEGF

Treatment for the active form of age-related macular degeneration is currently an injection of an “anti-vascular endothelial growth factor”, or “anti-VEGF”, into the eye. Injections may be repeated at 1 to 3 month intervals for some period of time depending on the response. Although this sounds painful, it is not … and very few people stop getting the shots because of discomfort.

Don’t Stop!
DO NOT PANIC or stop doing all that you need or want to do. Continue your job and hobbies! Vision Rehabilitation has training, techniques and devices that allow even those with severe vision loss to continue to function as they always have. From simple stronger glasses to advanced electronic devices, much help is available. Developments in technology in the last few decades have made this easier than ever. Ask your doctor for a referral to a low vision rehabilitation clinic. You will be glad that you did!

Summary … “What Do I Do?”

  • If you are a smoker, STOP! Smoking increases the chances of continuing “active” AMD with bleeding and vision loss
  • See your primary doctor for control of blood pressure, cholesterol and general health
  • Exercise. Ask your primary doctor about this.
  • Eat a diet rich in green leafy vegetables.
  • Consider taking vitamins. There are some preparations specifically for people with ARMD. Ask your eye doctor about this. There are guidelines and the vitamins are high in antioxidants.
  • When outside, wear sunglasses with UV and blue light protection and a hat with a visor or broad brim.
  • If your vision is affected, see a vision rehabilitation specialist or clinic
  • If your eye doctor advises, look at an Amsler grid. (see MAGNIFIER Issue #117 for details).
  • See your eye doctor and retina specialist as often as advised or sooner if your vision changes

Joe Fontenot MD, CLVT
Medical Director, Community Services for Vision Rehabilitation – 600 Bel Air Blvd, Suite 110, Mobile AL 36606

5 New Treatments on the Horizon

Newest Sustained-Release Anti-VEGF Drug in Trials

EyePoint Pharmaceuticals, Inc. announced on January 28, 2021 that the first patient has been dosed in their Phase 1 clinical trial of EYP-1901. EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration (wAMD). It is the newest of several sustained delivery drugs under study, this one promising to extend treatments from 4-6 weeks to only twice a year.

Faricimab for Wet AMD Effective at 16-week Intervals

Genentech has announced positive topline results from its Phase III studies, TENAYA and LUCERNE, evaluating its new drug faricimab for people with wet (neovascular) age-related macular degeneration (nAMD). Both studies have shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving injections every 4-6 weeks.

Zimura Shows Significant Suppression of GA
(late stage dry macular degeneration)

IVERIC bio, Inc. has announced positive Phase 3 results from its GATHER1 clinical trial with Zimura (avacincaptad pegol). Zimura® inhibits complement factor C5, which is believed to be involved in the development of AMD. The reduction in the mean rate of geographic atrophy (GA) growth over 12 months was better than 27% group as compared to sham control groups. The data was statistically significant, and the drug was generally well tolerated. GATHER2 is currently underway to further evaluate the efficacy and safety of Zimura in patients with GA.

Lucentis Substitute In Phase 3 Trials

Samsung Bioepis is reporting first year results from their phase 3 study of a proposed lucentis biosimilar (SB11). A biosimilar is a biological product (derived from a living organism) that shows no clinically meaningful differences from another biologic (eg. Lucentis). This study has shown that, at 52 weeks, primary end points were met for visual acuity and retinal health, suggesting that it could become a substitute for Genentech’s Lucentis (ranabizumab). This would be the first biosimilar for an anti-VEGF drug, which could lead to significant cost savings for the U.S. health system and consumers.

APL-2 Slows Progression of Early Disease in Patients with Geographic Atrophy

Apellis Pharmaceuticals,Inc. announced their analysis of the Phase 2 FILLY study investigating intravitreal pegcetacoplan (APL-2) for the treatment of geographic atrophy (GA), also known as advanced dry macular degeneration. The post hoc analysis found that the monthly treatment reduced the rate of progression to GA by 39 percent in areas of the retina outside of existing GA lesions.

APL-2 is the only targeted C3 therapy in Phase 3 clinical trials for GA, which affects approximately five million people globally and has no approved treatment. According to SriniVas Sadda, M.D., President & Chief Scientific Officer of the Doheny Eye Institute and lead investigator, “This study provides exciting evidence to support further exploration of the potential of pegcetacoplan for earlier intervention in the course of GA.”

Reminders for Using an Eyedropper

  1. Follow your doctor’s instructions exactly as to when & how
  2. If your medication can be refrigerated, the cold will help you to know where the drop landed
  3. Wash your hands before and after. Shake the bottle. Do not touch the dropper tip after removing the cap
  4. Tilt your head back, look up, use one hand to lower the eyelid down (away from the eye) to form a pocket below the eye
  5. Squeeze the bottle gently and let one drop fall into the pocket
  6. Close your eyes … Do not blink!
  7. Apply gentle pressure to your tear ducts (near your nose) and hold for a minute or two until the medication is absorbed into your eye (instead of draining into your nose)
  8. If any drops leak out, use a tissue to wipe them from your closed eyelids

AAO – American Academy of Ophthalmology

Brolucizumab and Retinal Vasculitis

The intraocular inflammation that may occur after intravitreal therapy with brolucizumab (Beovu) can also be accompanied by retinal vasculitis severe enough to cause profound loss of vision, researchers have found.

Source: American Academy of Ophthalmology (AAO). Linda Roach: EyeNet Magazine July 2020

Real-world outcomes. This retro­spective analysis of retinal vasculitis in 15 eyes of 12 patients from 10 U.S. centers was the first case series pub­lished in a peer-reviewed journal since isolated reports of brolucizumab-asso­ciated problems began emerging earlier this year.

The patients’ mean visual acuity (VA) before treatment with broluci­zumab was 20/53. By the time retinal vasculitis was diagnosed, it was 20/191 (range, 20/25 to 20/1,600). And at a mean of 25 days following diagnosis and treatment, it was 20/136. Nine eyes (60%) lost 3 lines or more, and five eyes (33%) had VA of less than 20/200.

The vasculitis and intraocular in­flammation noted in these eyes ranged from “peripheral vasculitis to occlusion of large retinal arteries around the optic nerve or macula with severe vision loss,” the researchers said. All 12 affected patients were women, which suggests that autoimmunity may be a factor, said coauthor Scott D. Walter MD, MSc, at Retina Consultants in Hartford, Connecticut.

Insidious onset. These adverse outcomes occurred in a pattern distinct from anything ever seen with other approved anti-VEGF drugs, said Dr. Walter, also at the University of Connecticut School of Medicine in Farmington. Specifically, the inflam­mation associated with brolucizumab “tends to be milder in its early stages and more insidious in onset,” he said. “The patient might not become symptomatic for several weeks after the injection, and the inflammation may be mild enough that patient wouldn’t think to call the office.”

In some patients, “the inflammation was picked up when they returned for a scheduled injection,” Dr. Walter noted. In others, he said, “It was overlooked because there was no intense vitritis or hypopyon.” These are typical signs of intraocular inflammation associated with other anti-VEGF drugs, with onset typically in the first week after injection, he said.

Additionally, “There were multiple exposures to the drug in some cases, and a delay of weeks, as opposed to days, before the onset of clinically apparent intraocular inflammation and retinal vasculitis,” Dr. Walter said. “And if you miss catching this, then it can really get you into trouble.”

If you use brolucizumab. Retina specialists should be alert for inflam­mation and other events when using brolucizumab, the study authors said. And while researchers try to discover the mechanism behind the problems, Dr. Walter said that he has decided against starting his patients with age-related macular degeneration on brolu­cizumab, and that he is encouraging those already on it to switch to another anti-VEGF agent.

But for those clinicians who do use the drug, Dr. Walter advises a complete examination of both the anterior and posterior segments to evaluate for subtle signs of inflammation—even for appar­ently asymptomatic patients—before each subsequent injection. “The most important thing for anyone treating these patients is to not reinject an eye that has active inflammation with brolucizumab or any other anti-VEGF drug.”

AAO Source Article with Full Disclosures

How to Wear a Surgical Face Mask

We are all wearing face masks of one kind or another these days. If it’s not bad enough to have limited central vision, some of us also wear glasses that tend to fog up when using a medical procedure mask. Fortunately, Dr. Yang has published a video that may solve that problem for us. It’s intended for medical students, but I’m sure we can pick up a few practical pointers.

“Hands Off” Environmental Controls

by Keith Colgan – Macular Degeneration Foundation

Call it “research” for the Foundation … or just plain laziness, but for the past two years my wife and I have been using a device that allows us to control much of our environment without lifting a finger. Good vision is not a problem for me, but good balance is. So when I enter a room at night, the ability to turn on a light with a simple voice command is important for my safety.

Photos of Echo Show and Echo Dot by Amazon

Multiply my needs by a thousand for those who are blind or live with the challenges of low vision. Here are two video’s that provide a good idea of what the Echo Show and Echo Dot by Amazon can do for you.

The AMSLER GRID

Written by: Liz Trauernicht – MDF President
Edited by: Joe L Fontenot MD

What is an AMSLER GRID?

Photo of Liz Trauernicht, President of the Macular Degeneration Foundation

The Amsler Grid is basically a square of horizontal and vertical lines. According to one source, a similar design may have been used in the late 1800’s. But the Amsler Grid we know today gets its name from Marc Amsler, a Swiss ophthalmologist who began promoting its use in 1947.

When used properly, it can help the user to detect visual distortions and loss of vision caused by such diseases as macular edema, central serous chorioretinopathy (CSC) and age-related macular degeneration (AMD).

Early detection of macular disorders is very important … especially today when effective treatments are available when caught early in the process. The Amsler Grid has helped people with macular disease to identify changes in their condition and report it to their eye doctor for evaluation.

What Forms Do Amsler Grids Take?

1. Amsler Grids on paper are the most common form and are available from your doctor and many sources over the Internet. In an attempt to improve accuracy, some use colored backgrounds and lines, while others use a special number of lines and line spacing.

2. Amsler Grid “Apps” are also available for mobile devices like your tablet or cell phone. These are just three that can be downloaded:

For All Devices:
Blindspot Amsler Grid ™ – Download and save for use with any cell phone or tablet. (instructions)

Android Specific:
https://play.google.com/store/apps/details?id=com.ossibussoftware.amsler

Apple Specific:
https://apps.apple.com/hu/app/eyecare-amsler-grid-eye-test/id1016180237

3. Portable viewer: We evaluated a portable key chain “viewer”. It is a novel approach, but we found it to be imprecise and subject to misinterpretation.

4. If you prefer using your computer monitor to check your vision, we have a specialized Amsler Grid called the “Blind Spot Amsler™” available using this link.

How to Use the Amsler
(American Academy of Ophthalmology)

Limitations of the AMSLER GRID

Because the Amsler Grid has limitations, some eye care professionals do not recommended it as a way to “self-assess” disease progression. Here are some of the reasons why:

1. It requires reasonably good near vision to discern the grid lines.

2. Poor patient compliance. Meaning, not everyone is willing or able to maintain a good routine of self-assessment.

3. It is a “subjective” test and prone to misinterpretation.

4. When compared to the tools available to eye doctors, the Amser Grid detects only about one-half of the areas in the visual field where vision is absent or deficient.

5. The eyes and brain can play tricks on you. One of these is called “Perceptual Completion”. This is when the brain fills in or completes gaps in the visual field of each eye. Another challenge is called “Central Fixation”, which causes visual confusion when looking at multiple lines. Perceptual completion and central fixation can make the Amsler Grid unreliable.

Specialized Amsler Grids

A search of the Internet will find references to these less common, high-tech Amsler Grids.

* Threshold Amsler Grid (TAG)

* Accelerated Amsler Grid

* Deformable Amsler Grid

* Three-dimensional Computer-automated Threshold Amsler Grid (3D-CTAG)

These (and other) modified Amsler Grids are attempts to improve the test for use at home between routine eye examinations. Progress is being made in the area of computer and tablet based software to identify macular disorders. All, however, have limitations that make regular visits to your optometrist, ophthalmologist and/or retinal specialist the best way to monitor your vision.

Summary

1. First and foremost, have your eyes examined on a regular basis. How often depends on your age, risk factors and whether you currently wear eyeglasses or contact lenses. Most eye care professionals recommend a comprehensive test every year or two.

2. If you notice a change in your vision, contact an eye care professional immediately.

3. If you have a diagnosis of macular degeneration, an AMSLER GRID may be useful as a “follow-up” tool for monitoring changes in your central vision between eye exams. However, it should never be used to screen yourself for macular disease. Leave that to a trained professional.

“Pitching” Blue Light Protective Eyewear

The Macular Degeneration Foundation published a Special Edition of its Newsletter in July of 2019. It detailed ten common misconceptions regarding macular degeneration. One was the idea that cell phones, televisions and computer screens damage the eyes with “blue light”. The truth is “no scientific evidence has yet revealed that light from such devices causes eye damage”.

The following video, produced in November of 2019 by the Canadian Broadcasting Corporation, interviews Dr. Sunir Garg, an eye surgeon and spokesman for the American Academy of Ophthalmology.

Macular Degeneration Foundation Supports VIS Group

Crossville Chronicle – October 2019: Crossville. Tennessee residents first met Liz Trauernicht, President of the Macular Degeneration Foundation (MDF), when she spoke at the 2014 VIS (Visually Impaired Support Group of Cumberland County) Group’s biennial InSight on Vision. She gave a rousing demonstration of her care for those afflicted with vision loss, especially those diagnosed with AMD.

While Liz was staying in Crossville, she visited the Fair Park Senior Center, bringing info about AMD and leading a lively discussion. Linda Simmons shares, “Since 2014, VIS has been most fortunate to have received tremendous support and loyalty from Liz and the MDF. We can’t be more earnest relating to our community how the MDF has been so important to the VIS Group’s ability of providing important programs for the blind and visually impaired; through the VIS On-Loan Equipment program, the printing of our Resource Guide, monthly support meetings, InSight on Vision, community programs, and monetary support of the TN Council of the Blind and the TN Organization of the Deaf/Blind.”

How smoking can harm your eyes

Statistics have shown that only 1 out of 5 smokers actually are aware of the risk smoking has on their eye health. The following information may convince folks that breaking the habit is imperative to insure a long and healthy life!

1. Cigarette smoke contains toxic chemicals that can irritate and harm the eyes. For example, heavy metals, such as lead and copper, can collect in the lens – the transparent bit that sits behind the pupil and brings rays of light into focus – and lead to cataracts, where the lens becomes cloudy.

2. Smoking can make diabetes-related sight problems worse by damaging blood vessels at the back of the eye (the retina).

3. Smokers are around three times more likely to get age-related macular degeneration – a condition affecting a person’s central vision, meaning that they lose their ability to see fine details.

4. Smokers are 16 times more likely than non-smokers to develop sudden loss of vision caused by optic neuropathy, where the blood supply to the eye becomes blocked.



Criteria for Cataract Surgery

Philip C Hessburg MD

What are the indications for cataract surgery? In short: One should consider having cataracts removed when one’s vision has fallen to levels where he/she cannot do the things one needs – or wants – to do.

If a Delta pilot’s vision drops a line or two, perhaps to 20/25 on the chart due to advancing cataract, it is time for surgery if he /she wants to maintain flying status. While my very elderly illiterate European-born grandmother, whose main joy in life was knitting mittens for 37 Minnesota-based grandchildren, didn’t need cataract surgery though she was probably legally blind (i.e. 20/200 or lower), she was happy knitting mittens.

But what if the patient also has AMD? For many years, ophthalmologists delayed surgery almost until the patient was blind before surgery. Today that is not the case. Today the indications for surgery are no different for patients with or without macular degeneration.

Why the difference?

The difference lies in the revolution which has occurred in cataract surgery over the past 50 years. In the early years of cataract surgery with intraocular lens implantation, the surgery itself was so traumatic that it frequently was associated with profound post-operative inflammation which would – and did – worsen the macular degeneration by inducing inflammatory changes throughout the eye.

Photo of Modern Cataract Surgery

Modern cataract surgery, as practiced today by our many fine American cataract surgeons, is so atraumatic that the eye barely knows it has been operated on. In days gone by the incision in the eye was 12-15 mm in length and required six or ten sutures to adequately close. Today cataract surgeons work through a 1.5 mm incision, usually requiring NO sutures to affect a watertight closure.

So today even patients with far advanced macular degeneration are advised to have their cataracts removed. And, although there may be no measurable improvement in the measured central vision on the wall chart, these patients are often among the happiest and most grateful because of their improvement in color vision, in peripheral vision, and in overall “performance vision”. Such patients are also far less prone to stumbles and falls after such surgery.

In summary, forget the old guidelines. Today, cataract surgery often makes a tremendous difference even in patients with far-advanced macular degeneration.

Modern cataract surgery truly can be a modern miracle.

So what does it mean to be blind?

by Philip C Hessburg MD

Well, literally, total loss of all light perception is absolute blindness. That patient would have no perception of light, would not know whether the sun has come up. Fortunately, perhaps as few as 10 or 15% of all people who qualify as “blind” are absolutely blind The rest have levels of sight which range from the ability to perceive light up to levels which would qualify as “legally blind”.

Icon of blind person walking with cane

Legal blindness, that level which would qualify the patient for social and government purposes and benefits as “blind”, is usually determined to be 20/200 or below. With that level of vision a person may not be able to read, or drive, or recognize faces very well, but can still get around the house and in society at a level which many folks would not immediately recognize as “that person is blind”. Most patients at that level of vision, that is who are legally blind, do not usually need or use a white cane or a leader dog. This includes, at least in my experience, most patients with far advanced macular degeneration.

Thus, it is important for people with macular degeneration to know that this disease does not result in absolute blindness. At its most profound state, and with modern medical management today this is increasingly rare, age related macular degeneration knocks out the central vision, (that from the macula or center of the retina), and the patient retains peripheral or “side vision”.

If one thinks of this in terms of letters on the eye chart on the wall, macular degeneration may knock vision down to 20/300 or even lower but never cause total loss of vision. (20/300 would mean that this patient would have to walk up to within 20 feet of the chart on the wall to read what the normal person could read from three hundred feet.)

So, in summary , though age related macular degeneration remains a very serious problem, it is increasingly manageable by our gifted ophthalmologists who specialize in retinal diseases. And, unless the patient is also afflicted with some other concurrent serious eye problem (such as glaucoma) the patient will not go totally blind.

New Study Reveals Benefits of Augmented Reality Glasses

Source: Mark Humayun, MD, PhD, director of the USC Dr. Allen and Charlotte Ginsburg Institute for Biomedical Therapeutics, codirector of the USC Roski Eye Institute and University Professor of Ophthalmology at the Keck School of Medicine.

In a new study of patients with retinitis pigmentosa, an inherited degenerative eye disease that results in poor vision, researchers have found that adapted Augmented Reality (AR) glasses can improve patients’ mobility by 50% and grasp performance by 70%.

“Patients with retinitis pigmentosa have decreased peripheral vision and trouble seeing in low light, which makes it difficult to identify obstacles and grasp objects. They often require mobility aids to navigate, especially in dark environments,” said Anastasios N. Angelopoulos, study project lead in Humayun’s research laboratory.

“Currently, wearable low vision technologies using virtual reality are limited and can be difficult to use or require patients to undergo extensive training. Using a different approach — employing assistive technology to enhance, not replace, natural senses — our team adapted AR glasses that project bright colors onto patients’ retinas, corresponding to nearby obstacles,” Humayun said.

Patients with retinitis pigmentosa wore adapted AR glasses as they navigated through an obstacle course based on a U.S. Food and Drug Administration–validated functional test. Using video of each test, researchers recorded the number of times patients collided with obstacles, as well as the time taken to complete the course. Patients averaged 50% fewer collisions with the adapted AR glasses.

Patients also were asked to grasp a wooden peg against a black background — located behind four other wooden pegs — without touching the front items. Patients demonstrated a 70% increase in grasp performance with the AR glasses.

How the AR system works

Artist's rendering of objects seen through the Augmented Reality glasses

The AR system overlays objects within a 6-foot wireframe with four bright, distinct colors. In doing so, the glasses provide visual color cues that help people with constricted peripheral vision interpret complex environments, such as avoiding obstacles in dimly lit environments.

To accomplish this, researchers used a process called simultaneous location and mapping, allowing the AR glasses to fully render the 3D structure of a room in real time. The glasses then translated this information into a semitransparent colored visual overlay, which highlighted potential obstacles with bright colors to help patients with spatial understanding and depth perception.

“Through the use of AR, we aim to improve the quality of life for low vision patients by increasing their confidence in performing basic tasks, ultimately allowing them to live more independent lives,” Angelopoulos says.

According to Humayun, while major cost and technical issues remain, this type of assistive technology could eventually become more practical for everyday use in the near future.

=================

Common Misconceptions Regarding Macular Degeneration

True or False Image

by Dan Roberts
MD Foundation Resource Director
888-866-6148

Age-related macular degeneration (AMD) is a progressive disease of the retina wherein the light-sensing cells in the central area of vision (the macula) stop working and eventually die. The disease is thought to be caused by a combination of genetic and environmental factors, and it is most common in people who are age sixty and over.

AMD can be a confusing diagnosis. With so many facets to its diagnosis, symptoms, pathology, and treatment … misunderstandings flourish. Here are ten of the most common misconceptions, each followed by a straight explanation based upon current knowledge.

Misconception #1: “AMD causes blindness.”

Truth: At its worst, AMD will damage only the center of the retina at the back of the eye. This area, the macula, comprises less than 5% of the total retina, but it is responsible for about 35% of the visual field. That means that a person with both eyes affected will eventually find it difficult or impossible to read, drive, or recognize faces.

The peripheral vision, however, is left untouched, so macular degeneration does not, by itself, lead to blindness. Many affected people move about with little or no assistance and lead independent, productive lives. The most successful of them have also learned to use a wide variety of assistive devices such as magnifiers, special bioptic glasses, navigation software, and electronic readers to maximize their peripheral vision and other senses.

Link: What is Macular Degeneration?

Misconception #2: “AMD is a growing epidemic.”

Truth: Recent research has found that the risk of developing AMD has been dramatically lessening over three generations. For that matter, Baby Boomers (born between 1946 and 1964) may experience better retinal health over a longer period of time than the two previous generations. The Baby Boomers and the new Generation X populations are already seeing comparable declines in AMD incidence, attributed possibly to better environmental conditions, sanitation, nutrition, and prevention strategies.

That said, the number of people with visual impairment or blindness in the United States is still expected to double by the year 2050. This is due, though, to the aging population increase, not by any dramatic escalation of the disease risks.

Misconception #3: “Wet and dry AMD are separate diseases.”

Truth: Dry AMD is distinguished by yellowish deposits of cellular debris (“drusen”) in the retina. The material comprising drusen is usually carried away by the blood vessels, but that ability is diminished in AMD.

About 10-15% of dry AMD cases progress to the “wet” form, in which immature blood vessels grow and leak into the retinas of people who have a high genetic inflammatory response. Inflammation is the body’s way of trying to deliver nutrition to injured or diseased tissue. The process is beneficial to the rest of the body, but it can cause scarring and central vision loss if not treated in time.

Therefore, Wet AMD is normally an adverse result of dry AMD, not a separate disease state. People with a normal inflammation response are usually not affected.

Lantern

Misconception #4: “Reading in dim light will make AMD worse.”

Truth: “Turn on the light”, said Grandma. “You’re going to ruin your eyes.” She meant well, but her suggestion should have been simply, “Turn on the light. You’ll be able to see better.”

Eyes are damaged no more by reading in dim light than are ears by listening to soft music. Actually, the wearing demand on the sight cells increases as the light grows brighter, which may prove harmful to the vision of people with retinal deficiencies. The wisest approach would be to compromise between “enough light to see by” and “too much light.”

Television Set

Misconception #5: “Viewing cell phone, television, and computer screens damages the eyes.”

Truth: No scientific evidence has yet revealed that light from such devices causes eye damage. The sun and full spectrum lamps which imitate the sun’s high blue content are the two strongest and most harmful sources of light.

By comparison, blue light intensity from cell phones, television, and computer screens is much less than either of those sources. However, until we have more evidence, it may be prudent to simply follow sensible practices like limiting screen time, taking periodic breaks, and taking advantage of light-filtering options.

Link: Blue light research study results

Misconception #6: “Cataract surgery causes AMD”

Truth: The retina is located in the interior of the back of the eye, and cataract surgery replaces the lens at the front of the eye. For that reason, most retinal surgeons say that there is minimal danger of retinal complications from such surgery.

Cataract surgery will not restore vision lost from retinal disease, but replacement of a clouded lens can significantly improve remaining vision, while offering the doctor a clearer view of the retina. In light of the small risk, standard practice is to defer cataract surgery until vision loss from a cataract significantly reduces a patient’s quality of life. At that point, the benefit/risk ratio is sufficiently high to warrant the procedure.

Link: More information concerning Cataract Surgery & AMD

Stem Cell Illustration

Misconception #7: “Stem cell replacement can cure AMD”

Truth: The media has been full of news about stem cell therapy as a future treatment for AMD. It is true that, in trials, stem cells are replacing the retinal pigment epithelium (RPE) layer that supports the sight cells (photoreceptors). And it is true that scientists are now beginning to replace damaged photoreceptor cells in animal models.

As exciting as this is, stem cell replacement will not be a cure for AMD. Like a patch on a tire, it can restore vision for a time (maybe even until the end of life) but it does not address the underlying cause of the disease. The cure will more likely come from the field of gene replacement therapy, which is still several years down the road.

Link: More information on Stem Cell Therapy

Misconception #8: “Anti-VEGF drugs for wet AMD will reverse vision loss.”

Truth: The anti-VEGF (antiangiogenic) drugs for treatment of wet AMD are designed only to block new blood vessel growth. The intent is not to restore vision, but to maintain current vision and prevent future damage. Some patients, however, do see an improvement after initial injections, but that is mostly due to diminished swelling of the retina and gradual dissipation of collected blood.

While anti-VEGF drugs can effectively stop rapid vision loss from uncontrolled blood vessels, most patients with wet AMD will continue to experience a gradual decline in vision over months and years until new treatments for geographic atrophy (advanced dry AMD) are available. Such treatments are now in trials.

Vitamin Pill Illustration

Misconception #9: “Special glasses, eye exercises, electrical stimulation, acupuncture, and nutritional supplements can reverse AMD.”

Truth: Nothing has yet been developed that will reverse AMD. Special prismatic lenses can redirect the wearer’s focus onto a healthier part of the retina. Magnification can enlarge an image to where it can be seen better peripherally. Eye exercises, electrical stimulation, and acupuncture can improve blood flow, temporarily improving visual acuity. And certain nutritional supplements can help to slow the progression of the disease. But once the retinal cells have begun to show the effects of aging, no lens, device, or vitamin can reverse AMD.

Research Lab Illustration

Misconception #10: “Nothing can be done”

Truth: By saying that nothing can be done about AMD, a doctor is saying that there is nothing medically that can be done other than anti-VEGF treatment for the wet form. AMD is incurable at this time, but hard-working researchers are close to providing answers. Meanwhile, there is much than can be done to maintain a person’s quality of life with visual impairment. Low vision rehabilitation can provide a strong foundation of knowledge and skills. Assistive devices and computer software equip low vision people with nearly every possible substitute for lost vision. And patient support organizations are ready to provide information and helpful social contact with others who share similar experiences.

Link: Raise your hopes … see up-to-date Video Interviews with with the world’s leading Research Scientists

Tablet System for those with Low Vision

The MagniLink TAB is a new tablet-based system by LVI Low Vision International. It is “pricey” at over $4000, but claims to offer high performance and user-friendly operation.

The Most Beautiful Flower

Rose Flower

by Cheryl L. Costello-Forshey

The park bench was deserted as I sat down to read
Beneath the long, straggly branches of an old willow tree.
Disillusioned by life with good reason to frown,
For the world was intent on dragging me down.

And if that weren’t enough to ruin my day,
A young boy out of breath approached me, all tired from play.
He stood right before me with his head tilted down
And said with great excitement, “Look what I found!”

In his hand was a flower, and what a pitiful sight,
With its petals all worn — not enough rain, or too little light.
Wanting him to take his dead flower and go off to play, I faked a small smile and then shifted away.

But instead of retreating he sat next to my side
And placed the flower to his nose and declared with overacted surprise,
“It sure smells pretty and it’s beautiful, too.
That’s why I picked it; here, it’s for you.”

The weed before me was dying or dead.
Not vibrant of colors, orange, yellow or red.
But I knew I must take it, or he might never leave.
So I reached for the flower, and replied, “Just what I need.”

But instead of him placing the flower in my hand,
He held it midair without reason or plan.
It was then that I noticed for the very first time
That weed-toting boy could not see: he was blind.

I heard my voice quiver, tears shone like the sun
As I thanked him for picking the very best one.
“You’re welcome,” he smiled, and then ran off to play,
Unaware of the impact he’d had on my day.

I sat there and wondered how he managed to see
A self-pitying woman beneath an old willow tree.
How did he know of my self-indulged plight?
Perhaps from his heart, he’d been blessed with true sight.

Through the eyes of a blind child, at last I could see
The problem was not with the world; the problem was me.
And for all of those times I myself had been blind,
I vowed to see the beauty in life, and appreciate every second that’s mine.

And then I held that wilted flower up to my nose
And breathed in the fragrance of a beautiful rose
And smiled as I watched that young boy, another weed in his hand,
About to change the life of an unsuspecting old man.

Speak! Text Reader App for Android

SPEAK Text Reader App Image

Text readers for the vision impaired are now commonly available for desktop computers. As the technology improves, new mobile apps for cell phones are becoming more powerful and therefore more useful.

Speak! is a brand new one (as of this date) that’s available for Android devices on the Google Play Store. Currently in “Beta”, which means it’s still under development, Speak! performed beautifully on my Samsung Model S8.

Here are a few of its features:

Speek Text Reader App Image

Automatically detects relevant text in an image

Automatically detects the language

Supports very small and far away text

Captured text may also be viewed and enlarged with various background colors

If you give it a try, please let us know how you used it and whether it met your expectations.

“Which is better … 1 or 2?”

If you have been to an eye care provider because you wanted to know if glasses would help you to see better, you’ve probably been asked this question … more than once.

This question is asked while performing a refraction and it can be a nerve racking question. You feel like you don’t want to give the wrong answer and sometimes you just cannot tell which is better. Rest assured, if you cannot tell which is better, then “I cannot tell” is the right answer!

What is a “refraction”?

The refraction is a process that begins with the use of a retinoscope or an autorefractor. These do not require any responses from you. They provide a starting point for the subjective refraction.

Typically during the subjective refraction a phoropter is used (shown above). The phoropter is the piece of equipment that you sit behind, looking through holes (that have lenses) at the visual acuity chart across the room. The phoropter allows the lenses to be changed easily and quickly as the question is asked, “Which is better, 1 or 2?”

However, there is another way to do a refraction. That is with a trial frame and loose lenses (see below). If you have low vision, this is the best way to have a refraction performed.

More on Refraction

Technically, refraction is the bending of light that takes place within the human eye. The goal of the light bending is to put the visual image (of the object that you are looking at) on the retina in the back of the eye.

As with almost all aspects of human anatomy and function, there are many variations and occasional malfunction. This can result in refractive errors. The shape of the cornea, the shape of the lens and the length of the eyeball are the main components that determine the distance refraction of the eye. Lenses are used to compensate for these refractive errors.

Typical Refractive Errors

Myopia (Nearsighted): Visual images come to a focus in front of the retina of the eye. This means you cannot see far away. A concave lens is used in your glasses to compensate for the myopia by moving the image back to the retina.

Hyperopia (Farsighted): Visual images come to a focus behind the retina of the eye. This means your eye muscles have to work harder to see, so it usually affects your close up vision first. A convex lens is put in your glasses to compensate for hyperopia by moving the image forward to the retina.

Astigmatism: Visual images do not focus in just one spot. This means you can have blurry vision both far away and close up. The lens in your glasses will bring the image into one focal point.

Presbyopia: When looking at an object close up, your eye cannot bring it into focus. This is due to aging. A convex lens compensates for the problem.

Does macular degeneration cause refractive disorders?

No, macular degeneration does not cause you to have refractive disorders. Macular degeneration affects the retina, but not the focusing apparatus of the eye. However, most people with macular degeneration are older so they have presbyopia. If this is not corrected by wearing lenses to refocus the image, the difficulty with vision caused by the macular degeneration will be aggravated, making seeing up close even more difficult.

Therefore, it is important for all with macular degeneration to see their eye doctor regularly and have a good refraction done.

Cheri Glaus OD, Optometrist
Joe Fontenot MD, CLVT Medical Director
Community Services for Vision Rehabilitatin(CSVR)
Mobile, Alabama

Tips for Thriving with Low Vision & Blindness

An exclusive video producted by the Macular Degeneration Foundation at the 2019 meeting of the Association for Research in Vision and Ophthalomogy (ARVO)

Gena Harper – Morgan Stanley Wealth Management Senior Vice President

Promising Update on APL-2 for Dry AMD

Statistically Significant Slowing of Disease Progression Seen at 12 Months APL-2 is a synthetic peptide which shuts down the complement activation system responsible for local inflammation, tissue damage (as in dry AMD) and the resulting blood vessel growth (angiogenesis in wet AMD).

Discovered by Professor John Lambris, University of Pennsylvania, APL-2 (formerly called POT-4) was the first complement inhibitor tested in patients with dry AMD, also called “geographic atrophy”. On Feb. 10, 2015, Apellis Pharmaceuticals announced the beginning of Phase I clinical trial of APL-2. The multi-center trials, labeled ASAP II, focused on establishing safety of intravitreal injections of APL-2.

After success at that stage in 2015, Apellis began a larger Phase II trial. Now the company reports that APL-2 has demonstrated a statistically significant slowing of geographic atrophy over 12 months, while appearing to increase in the second 6 months of the study. This represents a slowing of the rate of degeneration by almost half, according to Apellis founder and CEO Cedric Francois, MD, PhD. Plans are underway to move forward with Phase III in 2019.

More Information: APELLIS

Don’t Be Shy to Ask Your Primary Care Physician

A report from the National Poll on Healthy Aging reveals that more than half of older patients surveyed said their primary care providers have not asked them about their vision. Considering the number of ailments that can affect the aging population, vision is 3rd and unfortunately often overlooked.

This is concerning since the incidence of age-related macular degeneration (AMD) will likely increase as the number of senior adults grows. There is not yet a cure for the “dry” form of the disease, but the “wet” form (wherein blood vessels leak into the retinal layers) can be treated if caught early.

The survey solicited responses from 2,013 participants from ages 50 to 80 years with the following results:

• 58% said their primary health care provider did not ask about vision.
• 27% said they had been diagnosed with cataracts, diabetic eye disease, glaucoma or macular degeneration.
• 17% said they had their vision checked using an eye chart at a primary care visit.
• 91% had an eye exam within 2 years of a PCP asking about their vision.

The researchers wrote that “Findings from this poll underscore the important role that primary care providers play in promoting eye health. People with diabetes, a history of eye disease, or lower household incomes were more likely to have had a conversation about vision with their primary care provider, suggesting that primary care providers may be more likely to discuss eye health with those known to be at high risk for eye conditions”. AMD, however, does not always show symptoms until it has progressed significantly. For that reason, every senior adult should request that at least a cursory eye exam be performed at each annual physical.

Share Your Story

What's Your Story
Photo of Liz - President of the MD Foundation

We love to hear from our readers, especially those with an encouraging story. Have you found a practical way of coping with low vision that improved your quality of life? What activities bring you joy in spite of the many challenges? Please use our “Contact Form” to submit your story and we will consider it for publication. … Thank you, Liz

New Biomarker for AMD

by Adam Pope 1/23/19

Researchers from the University of Alabama at Birmingham Department of Ophthalmology and Visual Sciences, along with collaborators from the University of Iowa, have discovered a genetic biomarker that is associated with age-related macular degeneration and delayed rod-mediated dark adaptation.

“We have previously shown that delayed rod-mediated dark adaptation is the first functional risk factor for early AMD,” said Owsley, the Nathan E. Miles Chair of Ophthalmology. “Delayed dark adaptation means it takes these individuals much longer to adapt to a dark environment.” In other words, older adults with delayed dark adaptation have a heightened risk for developing AMD within the next few years.

In the recently published study, Owsley and Curcio, with collaborators Robert F. Mullins and Edwin M. Stone of the University of Iowa, established that older adults with delayed dark adaptation are also more likely to have these high-risk genetic polymorphisms at chromosome 1 and chromosome 10.

“This finding was the first genotype-functional phenotype association found in AMD research,” Owsley said. “What we find particularly exciting is that the ARMS2 genotype-phenotype association emerges even at pre-clinical stages of AMD … that is, in older adults who do not yet have AMD. Being able to assess risk at such an early stage could lead to new preventive measures”.

———————-

Cataract Surgery and AMD

Written By: Kierstan Boyd
Reviewed By: G Atma Vemulakonda, MD
Jan. 27, 2019

Can you have cataract surgery to restore some clear vision if you have macular degeneration?

Before recommending cataract surgery, your ophthalmologist will want to find out whether most of your vision loss is caused by the cataract or by the AMD. Some people who have a lot of damage to their retina from macular degeneration won’t see much or any vision improvement from cataract surgery.

Your ophthalmologist will examine your retina and take photographs to assess its condition. They will also take a look at how cloudy your lens is to see how much vision the cataract may be blocking. And before recommending cataract surgery, your ophthalmologist will check your vision to see if a change in your eyeglass prescription or even low vision magnifiers may be enough to see better. Having cataract surgery with AMD may not restore your ability to do up-close tasks, such as reading. Removing the cataract will allow more light to enter the eye, but that may not be enough for good central vision. We need a clear lens and a healthy retina for sharp vision.

Does Having Cataract Surgery Make AMD Worse?

Depending on the type of AMD you have, the answer is not fully known at this point. If you have the “dry” form of AMD, there is no evidence that cataract surgery will make your AMD worse. However, if you have the “wet” form, it is not clear if cataract surgery will negatively affect your macular degeneration. Cataract surgery causes inflammation inside the eye, which in theory could make wet AMD worse. However, results of multiple studies have been inconsistent, so we don’t know for sure if cataract surgery worsens wet AMD.

On the positive side, there is no evidence that having cataract surgery will make you more likely to develop dry or wet AMD if you don’t already have it.

Fortunately, for those struggling with the double whammy of vision loss from both AMD and cataracts, studies have shown that cataract surgery can improve vision in those who are candidates for the procedure. You and your ophthalmologist can discuss your options for achieving better sight.

——————————–