On behalf of the investigators for the OAKS, DERBY, and GALE clinical trials, Texas Retina’s Director of Clinical Research for Dallas, Ashkan Abbey, MD, co-authored an article titled, “Pegcetacoplan Treatment for Geographic Atrophy in Age-Related Macular Degeneration Over 36 Months: Data From OAKS, DERBY, and GALE” in the latest issue of the American Journal of Ophthalmology. GALE (NCT04770545) is a prospective open-label extension study following the 24-month, sham-controlled, Phase III OAKS (NCT03525613) and DERBY (NCT03525600) studies of pegcetacoplan (brand name Syfovre).

Highlights of the 12-month GALE results featured in the article include the following:

  • Across all eyes, pegcetacoplan reduced the mean rate of change in geographic atrophy (GA) up to 32%.
  • Pegcetacoplan demonstrated increasing efficacy over time through the overall 36-month period with up to a 42% reduction observed in eyes with non-subfoveal GA.
  • Safety outcomes were consistent with the OAKS and DERBY studies.

“GALE represents the first and longest prospective clinical trial to evaluate long-term treatment of patients with GA with an FDA-approved therapy,” shares Dr. Abbey. “It’s exciting to see that intravitreal pegcetacoplan remained well tolerated and continued to slow disease progression with as few as 6 injections per year. This is the first GA treatment to show a functional benefit, providing us a valuable tool to help protect our patients’ vision.”

Understanding Geographic Atrophy (GA)
Approximately 20% of patients with age-related macular degeneration (AMD) will develop GA, a leading cause of blindness impacting more than one million people in the United States. A progressive disease, GA is considered an advanced form of AMD and is caused by the growth of lesions that destroy the retinal cells responsible for vision (atrophy). Upon examination by an ophthalmologist or retina specialist, these areas of atrophy often look like a map which led to the term “geographic atrophy.”

More About Intravitreal Pegcetacoplan
The U.S. Food and Drug Administration (FDA) approved intravitreal pegcetacoplan (Syfovre), the first-ever treatment for GA secondary to AMD, in February 2023. Administered as an intravitreal injection, it was designed to regulate activation of the complement cascade, part of the body’s immune system that leads to the onset and progression of GA. Texas Retina was actively involved in the OAKS and DERBY clinical trials that led to the approval of intravitreal pegcetacoplan and is also part of the GALE study, which is evaluating the treatment’s long-term impact.

About Ashkan M. Abbey, MD
Dr. Abbey cares for patients in Texas Retina’s  Dallas Main and Rockwall offices and also serves as Texas Retina’s Director of Research for Dallas. You can learn more about him here.

Click HERE to learn about all of the clinical trials currently available at Texas Retina.