Clinical Trials for Geographic Atrophy EV 5/2013

Clinical Trials for Geographic Atrophy EV 5/2013

Posted on May.01, 2013, by , under Educational, Guest Blogger

Geographic atrophy (GA) is an advanced form of dry macular degeneration. While it does progress much slower than wet macular degeneration, the vision loss can be just as severe resulting in a large scotoma or grey, blurry or black spot right in the middle of one’s vision. Other vision changes include blurred vision, the need for more light, as well as colors appearing less vivid.

Just a few short years ago, there was not only no treatment for GA but very few clinical trials researching possible treatment options. Thankfully that is changing. At the time of this writing, May 2013, there are over 15 studies in different phases that are seeking to understand the risk factors for GA, identify how and why it progresses, and develop therapies to treat it.

Here is a sampling of some of the latest research going on for GA:

1. Oral Medication – ORACEA capsule daily for 24 months

2. Laser – Between 1 and 3 sessions of micropulse laser applied in the inferior hemiretina of the randomly selected eye

3. IV Infusion – Intravenous infusion of RN6G of 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg

4. Repeated Eye Injections – Repeated intravitreal injections of FCFD4514S

5. Single Eye Injection – Injection beneath the retina of Human Umbilical Tissue-Derived Cells (CNTO 2476)

6. Stem Cell Transplant – HuCNS-SC cells administered into the subretinal space through a standard surgical approach.

Each of these studies are in different phases. There are Phase 1, 2, 3 and 4 studies. Each of them with a different purpose. A Phase I study is looking at safety while a Phase II/III clinical trial is looking at efficacy and tolerability. Every study has a different set of criteria to be eligible to be a participant as well as a set of criteria that makes a person ineligible. Eligibility will include factors like age, diagnoses of dry macular degeneration, general health, and cognitive ability. Other conditions like diabetes, Parkinson’s, Alzheimer’s or cancer will make one ineligible. For these GA studies any current or past occurrences of wet macular degeneration excludes a patient from participating.

Many of these clinical trials are double blind, placebo controlled studies – which means that even if you or a loved one qualifies for the study, you may get a placebo or sham rather than the therapeutic treatment. To better understand how clinical trials work and what the different phases mean go to:

Macular Degeneration Clinical Trials

 

Leslie Degner, RN, BSN

www.WebRN-MacularDegeneration.com