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

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

The Evolving Contact Lens

4/22/14

Contact lenses give a person the ability to see without glasses. If you have keratoconus, they are essential for seeing as regular glasses don’t work with an irregularly shaped cornea. But lately these relatively simple lenses have created a whole new world where they can dispense eye medication, measure blood glucose levels and even help the blind see.

Courtesy Google
Courtesy Google

Monitoring Blood Sugar
You have heard about Google Glasses, but Google is looking beyond the smartphones of eye wear to monitoring health. They are currently working on a lens with tiny wireless chips and glucose sensors that are sandwiched between two lenses. They would monitor glucose levels once a second and use tiny LED lights, also inside the lenses, to flash when the levels are too high or low. And how big are these electronics? They are no larger than a speck of glitter, with a wireless antenna that is thinner than a human hair. While they are still in development – Google has run clinical research studies and is in discussions with the FDA – it could make blood sugar monitor far less invasive than pricking your finger several times a day.

Drug Delivery for Glaucoma
Getting glaucoma patients to regularly use their eye drops to regulate the pressure in their eyes has always been a problem. They forget, don’t want to be bothered, or have a hard time getting the drops into their eyes. This could change with two research projects exploring the use of contact lenses to deliver medication over a prolonged period of time.

Researchers at Massachusetts Eye and Ear/Harvard Medical School Department of Ophthalmology, Boston Children’s Hospital, and the Massachusetts Institute of Technology who are working on a lens designed with a clear central area and a drug-polymer film made with the glaucoma drug latanoprost, around the edge to control the drug release. These lenses can be made with no refractive power or the ability to correct the refractive error in nearsighted or farsighted eyes.

Another team from University of California, Los Angeles have combined glaucoma medication timolol maleate with nanodiamonds and embedded them into contact lenses. When the drugs interact with the patient’s tears, the drugs are released into the eye. While the nanodiamonds strengthen the lens, there is no difference in water content so they would be comfortable to wear and allow oxygen levels to reach the eye.

Seeing in the Dark
Researchers out of the University of Michigan have developed an infrared sensor that could eventually be used in the production of night vision contact lenses. Thanks to graphene, a tightly-packed layer of carbon atoms, scientists were able to create a super-thin sensor that can be stacked on a contact lens or integrated with a cell phone.

Stem Cells for Cornea Damage
Researchers in Australia are working on a way to treat corneal damage with stem cell infused contact lenses. Stem cells were taken from the subject’s good eye and then plated them onto contact lenses (if there is a defect in both eyes, stem cells are taken from a different part of the eye). After wearing for about two weeks the subjects reported a significant increase in sight.
Braille-Tracile-Contacts
Helping the Blind See
And what good are contact lenses if you are blind? At Bar Ilan University in Israel researchers are creating special lenses that translate images into sensations felt on the eye. It works by taking an image with a smartphone or camera, it is then processed and sent to the contact lens. The custom-made lens is fitted with a series of electrodes that use small electric impulses to relay shapes onto the cornea, similar to braille. After some practice, test subjects were able to identify specific objects.

In expanding the uses of contact lenses, these projects seem to be just the beginning, all reported in the first four months of this year. Researchers and developers are working together to find more and better ways help with vision and medical issues, using contact lenses.

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