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Recruiting Phase 2 NCT07174687

SGLT2 Inhibitors in Geographic Atrophy

Trial Parameters

Condition Retinal Degeneration
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 70
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2025-12-02
Completion 2027-12
Interventions
DapagliflozinMatching Placebo

Brief 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.

Eligibility Criteria

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 with the presence of non-foveal Geographic Atrophy (GA) 1. The geographic atrophy must not involve the center point of the fovea. 2. Total area of geographic atrophy must be between 2.5 mm2 and 17.5 mm2 (1 - 4 disc areas, respectively). 3. If the geographic atrophy consists of multiple lesions, at least one lesion must have an area of ≥1.25 mm² (equivalent to 0.5 disc areas). 6. BCVA between 20/25 and 20/320 7. Must be treatment-naïve for AMD, except for oral supplements Exclusion Criteria: 1. Prior investigational drug use within 60

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