Understanding Macular Degeneration Research

Understanding Macular Degeneration Research

Posted on Oct.31, 2011, under Innovations for Visually Impaired

Macular Degeneration Research

I often get many e-mails when some type of macular degeneration research is in the news. Patients and loved one are wanting to know when, where and how they can get this “latest treatment.” Unfortunately just because some research is in the news, doesn’t mean that the new treatment is even close to being available to the public. In fact it may be just a glimmer of hope that was discovered in a lab or in animals that has not yet even been tried in humans.

Take for example the stem cell study being done for dry age related macular degeneration. It was announced on January 3, 2011 that the FDA approved the application from  Advanced Cell Technology  to treat dry AMD using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells.  Even though the study sites had not yet been determined, many people were anxious to find out how they could participate in the study.

Clinical Trial Stages

There is a process or stages that all clinical trials follow. They begin as a  Phase I, and then if the initial reports are positive they move to a  Phase II, and then to a  Phase III and again if positive results are still seen they move to a Phase IV. Any study can be discontinued during any of these phases if the researchers find that the treatment is not safe or effective. So each study that is listed at the National Institute website (www.clinicaltrials.gov) will list what phase the study is in.

Clinical Trial Number of Participants

The number of participants allowed into the study is determined prior to the start of the study. Once the pre-determined numbers are reached no other participants are allowed to be in the research study. Phase I clinical trials will recruit only a small number (10 – 80) because this phase is determining the safety of the treatment. Phase II trials allow a larger group of people, typically in the 100 – 300 range to see if the new treatment is effective. In a Phase III the study will seek to confirm the effectiveness of the new treatment, monitor it for side effects and compare it to standard treatment.

Clinical Trial Criteria

All clinical trials list criteria that makes a patient eligible for a study and criteria that makes a patient ineligible.  For instance in the Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD) (COMPLETE) study patients must be 50 years old or older with a diagnosis of non-exudative (dry) macular degeneration. Criteria that would make a patient ineligible for this study would be a diagnosis of wet macualr degeneration. No exceptions can be made or study results would be flawed.  Perhaps with a better understanding now of how clinical trials work, you may want to find out more specifics on what is happening with macular degeneration research:

Macular Degeneration Research

Leslie Degner, RN, BSN

Better Health for Better Vision