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.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Participant is male or, if female, participant is surgically sterilized or amenorrheic for at least one year
≥50 years old
Prior investigational drug use within 60 days
Use of other SGLT2 inhibitors
History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP < 90mmHg) at baseline
Type I and Type II Diabetes Mellitus
Parallel
Dapagliflozin
DrugDapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
Matching Placebo
Other interventionMatching oral placebo to dapagliflozin
Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12
The square root GA lesion size (i.e. transformed area of GA) was measured by FAF photographs at baseline and 12 months. Baseline is defined as the last available, non-missing observation prior to first study drug administration.
Mean Change From Baseline in Drusen Size in the Study Eye at Month 12
The mean change in size of drusen volume measured by OCT from Baseline to Month 12
Mean Change From Baseline in best corrected visual acuity (ETDRS letters) from Baseline to Month 12
The mean change in best corrected visual acuity (ETDRS letters) from Baseline to Month 12
Mean Change From Baseline in Dark Adaptation in the Study Eye at Month 12
The mean change in rod intercept time on dark adaptation from Baseline to Month 12
Mean Change From Baseline in low luminance best corrected visual acuity (ETDRS letters) from Baseline to Month 12
The mean change in low luminance best corrected visual acuity (ETDRS letters) from Baseline to Month 12
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