Evaluation of Alpha Lipoic Acid as a Potential Treatment for Geographic Atrophy in subjects with Age-related Macular Degeneration (GALA Study)
The GALA Study is a multi-center, double masked randomized clinical trial that will evaluate alpha lipoic acid (ALA) as a potential treatment for geographic atrophy (GA) due to age related macular degeneration (AMD). It is funded by the BrightFocus Foundation, Cures Within Reach, and the Pennsylvania Lions.
What is Geographic Atrophy and Why is GALA important?
Age-related macular degeneration is a leading cause of vision loss in Americans 60 years of age and older in the developed world. It affects the macula, the central part of the retina needed for sharp, clear vision and activities such as reading, sewing and driving.
There are two types of AMD, commonly known as wet and dry. In dry AMD, cells in the macula die. The advanced form of dry AMD is called geographic atrophy. Central geographic atrophy (CGA) causes vision loss through loss of photoreceptors (rods and cones) in the central part of the eye. Geographic atrophy (GA) from age-related macular degeneration (AMD) is responsible for approximately 20% of the legal blindness cases in North America, and there currently is no effective treatment to prevent its onset or progression.
The purpose of this study is to determine how effective alpha lipoic acid (ALA) is, when taken daily orally, for patients suffering from geographic atrophy due to age related macular degeneration. In addition, we wish to gather more information on the safety of ALA in these patients.
Status of the GALA Study
53 participants enrolled at 5 Clinical Centers throughout the US were randomized to receive either a daily dose of 1200 mg of alpha lipoic acid or a placebo. Patients will complete in-clinic visits at months 6, 12, and 18. The final patient visit is expected to occur in February 2019.
CPOB's Role in GALA:
The CPOB Coordinating Center provides expertise on study design, statistical analysis, database development and management. It is the Coordinating Center’s responsibility to ensure that the protocol is followed by all participating sites, and it serves a resource to the clinical centers, the Study Principal Investigator, and the Office of the Regulatory Sponsor.
The Scheie Image Reading Center also contributes to the GALA Study by providing expert grading of Fundus Autofluorescence (FAFs), color fundus photographs, and Spectral Domain Optical Coherence Tomography (OCTs) images taken of the study patients for determination of eligibility and study outcomes.
Additional information on the GALA study is available at www.ClinicalTrials.gov. Search for NCT number: 02613572.