Recruiting
Phase 2

SGLT2 Inhibitors

Sponsor:

Washington University School of Medicine

Code:

NCT07174687

Conditions

Retinal Degeneration

Retinal Diseases

Eye Diseases

Geographic Atrophy

Pathological Conditions, Anatomical

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin

Matching Placebo

Study Details

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.

Conditions

Retinal Degeneration

Retinal Diseases

Eye Diseases

Geographic Atrophy

Pathological Conditions, Anatomical

Study ID

NCT07174687

Start date

Dec 2, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met

1. The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits
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 in study eye, except for oral supplements

Exclusion Criteria

1. Prior investigational drug use within 60 days
2. Use of other SGLT2 inhibitors
3. History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP < 90mmHg) at baseline
4. Type I and Type II Diabetes Mellitus
5. End stage renal disease or estimated glomerular filtration rate less than 25 mL/min/1.73 m2 per MDRD calculation
6. History of heart failure
7. History of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA
8. 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

1. Any prior intravitreal treatment for any indication in the study eye.
2. 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
3. Prior exposure to complement inhibitor therapy for retinal disease in either eye at any time remains exclusionary
9. Any intraocular surgery or thermal laser within 3 months of date of randomization
10. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks
11. Any prior thermal laser in the macular region, regardless of indication (self-report)
12. Any evidence of choroidal neovascularization in study eye
13. Enrollment in another interventional trial during the trial period

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dapagliflozin 10 mg daily for 12 months

Dapagliflozin 10 mg daily PO for 12 consecutive months

placebo comparator: Matching Placebo for 12 months

Subjects will receive a placebo medication daily PO for 12 consecutive months

Interventions

Dapagliflozin

Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.

Matching Placebo

Matching oral placebo to dapagliflozin

Primary outcome measure

  • Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12 [ Time Frame: Baseline (screening) and Month 12. ]

Central Contacts and Locations

Central contacts

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Rajendra S Apte, MD PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 26, 2026

Last verified

Dec, 2025

Keywords

  • Geographic Atrophy (GA)
  • Age-related Macular Degeneration
  • AMD
  • SGLT2
  • Dapagliflozin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-26.