NCT07174687

SGLT2 Inhibitors in Geographic Atrophy

Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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-year period measured by fundus autofluorescence (FAF) , and secondary outcomes include structural and functional testing for visual function such as change in drusen volume as measured by OCT, dark adaptation, and low luminance BCVA to determine the effect of dapagliflozin on the progression of dry AMD. All subjects will return for a final follow-up visit at Month 12, marking the conclusion of the study.

Conditions

• Retinal Degeneration
• Retinal Diseases
• Eye Diseases
• Geographic Atrophy
• Pathological Conditions, Anatomical

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
OTHER	Matching Placebo	Matching oral placebo to dapagliflozin

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2025-09-16
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study