Washington University School of Medicine
AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form. Geographic atrophy (GA) is an advanced stage of dry AMD characterized by progressive retinal cell degeneration. The primary objectives of the study are to assess the safety, tolerability, and evidence of activity of SGLT2 inhibitors in subjects with Geographic Atrophy associated with AMD.
This is a Phase II, prospective, single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of oral dapagliflozin in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study will randomize approximately 70 subjects to obtain at least 60 evaluable subjects at a single center site. Subjects will be randomized in a 1:1 manner to receive: 1. Dapagliflozin 10 mg (oral) once daily 2. Matching placebo (oral) once daily Primary outcome of interest will be progression of GA lesion area over the 1-yea…
Inclusion Criteria 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures 3. Participant is male or, if female, participant is surgically sterilized or amenorrheic for at least one year 4. ≥50 years old 5. Evidence of dry advanced AMD, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met 1. The geographic atrophy may involve th…
Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
Matching oral placebo to dapagliflozin
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