Stem-Cell Clinics for AMD Treatments: Choose Wisely

People considering stem-cell therapy for eye-related issues need to take precautions in choosing clinics at which to have their procedures, warned Ocular Surgery News in January 2017. Patients should “find clinics that are licensed, associated with an academic center, have a history of running clinical trials and do not require patients to pay out of pocket.”

genetic research abstract blue background 3d illustration In a presentation to the American Society of Retina Specialists, Dr. Ajay E. Kuriyan of the University of Rochester reported that three patients who underwent bilateral intravitreal injection of stem-cells for age-related macular degeneration (AMD) suffered bilateral vision loss. The clinic at which all three procedures were performed did not have a licensed ophthalmologist on-site, and the stem-cell injections were administered by a nurse practitioner, Ocular Surgery News reported. Each patient paid $5,000 for the procedure.

Kuriyan told Ocular Surgery News that there are several warning signs for potentially dangerous clinics, including whether the facility is a standalone clinic that is not affiliated with an academic institution or has no history of conducting clinical trials. The other big warning sign, he said, is if patients are asked to pay.

“Stem-cell treatments hold great promise for the treatment of AMD and other eye conditions,” DEF Medical Director Dr. Anthony Nesburn said. “Patients — and physicians — need to take great care in choosing the right studies in which to access such treatments.”

Lauren Hauptman

Medical Research Funding Needs Individual Donors

The Need for Medical Research Funding

About 1.75 million U.S. residents currently have advanced age-related macular degeneration with associated vision loss, with that number expected to grow to almost 3 million by the year 2020.

About 8.4 million individuals worldwide are blind from primary open-angle glaucoma, with that number expected to grow to almost 11 million by the year 2020.

About 22 million Americans have cataracts affecting their vision, with that number expected to grow to more than 30 million by the year 2020.

The economic impact of this increase of people with vision loss will be tremendous.  But right now scientist are working on ways to treat and eventually cure many eye diseases.  The only problem is the funding necessary to support this sight-saving research. Here is a look at the decline of medical research funding in the US and what you can do to help.
medical research funding

3/17/15


 

Susan DeRemerSusan DeRemer, CFRE
Vice President of Development
Discovery Eye Foundation

Drugs to Treat Dry AMD and Inflammation

12/2/14

Below is an article from the monthly Macular Degeneration Partnership E-Update on potential drugs to treat dry AMD and inflamation. To learn more about dry AMD, including stem cell treatments, go to AMD.org. You can also subscribe and have the monthly newsletter delivered to your inbox.clinical trials for drugs to treat dry age-related macular degeneration

There are many causes of age-related macular degeneration and any of them may prove a good target for treatment for dry AMD. A long list of these was discussed at the recent Academy of Ophthalmology meeting. They were divided into the types of drugs being studied. We’ll look first at inflammation and the complement factor system, which is part of the immune system.

Inflammation is known to be associated with macular degeneration. The target may be the inflammation itself, or the cause of the inflammation.

Lampalizumab (or anti-Factor D) is a drug that is injected into the eye. In earlier Phase II trials, it was shown to reduce the area of the geographic atrophy by 20%. A Phase III clinical trial is now underway for individuals with geographic atrophy from dry AMD. Several research sites are actively recruiting now and many others will start recruiting in the near future. For more information and a list of participating centers, visit Clinical Trials.

LFG316 is also an antibody and an injection. This Phase 2 study is a randomized clinical trial of a drug that targets the C5 complement pathway (part of our immune system). It is designed to test the safety and efficacy of different doses of LFG316. There are three arms in the study: one group receiving a higher dose of the drug; one group receiving a lower dose of the drug; one group receiving a sham injection (no drug). These are successive monthly injections for people with geographic atrophy (GA). It is taking place in multiple locations throughout the U.S. and is sponsored by Novartis. For more information and a list of participating centers, visit Clinical Trials.

Oracea is a pill for dry macular degeneration, now in Phase II/III clinical trials around the U.S.. The pill contains doxycyline, which suppresses inflammation. Participants will be randomly assigned to either receive the drug or a placebo. More information at Clinical Trials.

Zimura by Ophthotech has been tested as a drug for wet AMD, but also seems to affect the drusen of dry AMD. Zimura targets the complement pathway plays a significant role in dry AMD. A Phase 2/3 clinical trial investigating ZimuraTM for treatment of geographic atrophy, is in the planning stages.

Eculizumab was also presented. This intravenous treatment for dry AMD did not show the desired effect in clinical trial, so no further development is planned at this time.

POT-4 is another drug that targets the complement factor system involved in inflammation. It is delivered through injection into the eye. The Phase I trial is completed and a Phase II clinical will be announced soon.

Iluvien is a drug delivery system that has been used in patients with diabetic retinopathy. A Phase II clinical trial for dry AMD is underway, though it is no longer recruiting patients. This is an implant inside the eye that releases fluocinolone acetonide. For more information, see Clinical Trials.

Judi Delgado - age-related macular degenerationJudith Delgado
Executive Director
Macular Degeneration Partnership
A Program of the Discovery Eye Foundation

New Hope for Corneal Scarring

5/22/14

There are several etiologies for limbal stem cell deficiency of the front of the eye. These include chemical and thermal burns, Steven-Johnson syndrome (which is an autoimmune severe allergic reaction that causes a burn from within), congenital aniridia, and a few other insults such as contact lens over-wear. All of these cause severe ocular surface scarring and problems with the cornea. Many eyes with these diseases have problems with corneal healing. They do not have the stem cells to support ocular surface health. The scarring can be so severe in many cases that severe corneal blindness can result.

Limbal stem cells from the human cornea, with a protein known as p63 stained yellow. Cell nuclei (which hold the DNA) are stained red.  From eurostemcell.org
Limbal stem cells from the human cornea, with a protein known as p63 stained yellow. Cell nuclei (which hold the DNA) are stained red. From eurostemcell.org

In these cases, a simple corneal transplant will quickly fail and not result in any visual improvement. The reason for this is that the stem cells of the ocular surface have been damaged or burned out.

Visual rehabilitation for these eyes usually requires a limbal-corneal stem cell transplantation. The stem cells can be taken from the other healthy eye of the same patient, a living related donor, and or cadaveric tissue. In most cases systemic immunosuppression medications need to be taken for 1 to 3 years following surgery in order to minimize risk of rejection. Management of these patients is done in conjunction with an immunologist or a transplant specialist who can co-manage and monitor for systemic toxicity while the patient is on the these immunosuppressive medications. As most of these eyes also have concomitant glaucoma and scarring of the eyelids to the globe, co-management with a glaucoma specialist and an oculoplastic specialist is also required.

For patients who cannot be on systemic immunosuppression for other health reasons such as diabetes or cancer, they may require an artificial corneal transplantation. The artificial corneal transplantation is reserved as a last step for visual rehabilitation in these eyes. The only artificial cornea that has shown potential, is the Boston keratoprosthesis. Even this artificial cornea carries a high risk for infection and glaucoma. Very close monitoring of eyes that have an artificial cornea is required to monitor for infection and glaucoma progression. However these eyes do not require systemic immunosuppression.

Eye with Boston keratoprosthesis
Eye with Boston keratoprosthesis


The management of eyes with severe ocular surface disease is a difficult one for the cornea specialist. A subspecialist in severe ocular surface disease and limbal stem cell transplantation is required to manage these very sick eyes. At the Gavin Herbert Eye Institute, we have developed a team approach for the management of severe ocular surface disease patients and have successfully treated and are managing many patients who have otherwise no place to go.

Farid 3.6.14Marjan Farid, MD
Director of Cornea, Cataract, and Refractive Surgery
Vice-Chair of Ophthalmic Faculty
Director of the Cornea Fellowship Program
Associate Professor of Ophthalmology
Gavin Herbert Eye Institute, University of California, Irvine