Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
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
• Evidence of dry advanced AMD with the presence of non-foveal Geographic Atrophy (GA)
‣ The geographic atrophy must not involve the center point of the fovea.
⁃ Total area of geographic atrophy must be between 2.5 mm2 and 17.5 mm2 (1 - 4 disc areas, respectively).
⁃ 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).
• BCVA between 20/25 and 20/320
• Must be treatment-naïve for AMD, except for oral supplements