What You Need to Know About Clinical Trials for Geographic Atrophy Secondary to Age-related Macular Degeneration

Title What You Need to Know About Clinical Trials for Geographic Atrophy Secondary to Age-related Macular Degeneration
Author, Co-Author Steven Ferrucci, ERIN HENRI, AVANTI GHANEKAR
Topic Treatment and Management of Posterior Sgmt Disease
Year
2016
Day
Thursday
Program Number
165160
Room
Ballroom A-B
Affiliation
Southern California College of Optometry
Abstract

Background: Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) affects more than 1 million Americans, and there is no approved treatment. However, the pace of GA research has gathered considerable momentum in recent years. Several experimental therapies are now being investigated in phase 2 and 3 clinical trials. The purpose of this presentation is to provide clinical trial updates and discuss potential implications for GA patient management now and in the future.

Methods: Systematic search of interventional phase 2 and 3 studies registered on clinicaltrials.gov involving patients with GA secondary to AMD, using “conditions” search terms: "geographic atrophy" OR ((dry OR atrophic) AND age AND macular AND degeneration).

Results: Currently there are 18 ongoing interventional phase 2 and 3 clinical trials evaluating experimental GA therapies. Three phase 3 trials are assessing the efficacy of complement system inhibition (lampalizumab) and metalloproteinase inhibition (doxycycline), with primary efficacy endpoints of mean change in GA lesion area over time. Other ongoing phase 2 studies are investigating the efficacy of neuroprotection (brimonidine), complement inhibition (APL-2, CLG561, LCF316, Zimura), and other mechanisms (metformin, minocycline). In addition, there are 12 ongoing observational studies with primary outcomes designed to characterize the poorly understood functional and anatomic progression of GA over time.

Conclusions: More than 14,000 patients with GA are expected to participate in observational and interventional clinical trials.  Collectively, these studies will provide a wealth of information on GA natural history, and the efficacy and safety of numerous experimental therapies for reducing GA lesion progression over time. Considering that there are currently no FDA-approved or effective therapies for this disease, the near future holds great promise for patients and potential to reshape the way we manage geographic atrophy

Affiliation of Co-Authors GENETECH, GENETECH
Outline