SGLT2 Inhibitors in Geographic Atrophy

Prior treatment

• Prior investigational drug use within 60 days
• Use of other SGLT2 inhibitors
• Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures
  • Any prior intravitreal treatment for any indication in the study eye.
  • Prior intravitreal treatment (steroids, anti-VEGF) in the fellow eye is permitted if all injections occurred more than 6 months prior to screening, provided the participant has no active intravitreal treatment in either eye at screening or during the study period
  • Prior exposure to complement inhibitor therapy for retinal disease in either eye at any time remains exclusionary
• Any intraocular surgery or thermal laser within 3 months of date of randomization
• Any prior thermal laser in the macular region, regardless of indication (self-report)

Other illness

• History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP \< 90mmHg) at baseline
• Type I and Type II Diabetes Mellitus
• End stage renal disease or estimated glomerular filtration rate less than 25 mL/min/1.73 m2 per MDRD calculation
• History of heart failure
• History of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA
• Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks

Other

• Any evidence of choroidal neovascularization in study eye
• Enrollment in another interventional trial during the trial period

• 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, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met
  • The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits
  • 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 in study eye, except for oral supplements