Dapagliflozin (an SGLT2 inhibitor) for slowing geographic atrophy in dry AMD
Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
This trial will test whether taking dapagliflozin once daily can slow the growth of geographic atrophy in people aged 50 and older with dry age-related macular degeneration.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07174687 on ClinicalTrials.gov |
What this trial studies
This is a Phase II, single-center, randomized, double-blind, placebo-controlled study enrolling about 70 participants to obtain at least 60 evaluable subjects. Participants are randomized 1:1 to oral dapagliflozin 10 mg daily or matching placebo and followed for 12 months. The primary outcome is change in geographic atrophy lesion area measured by fundus autofluorescence over one year, with secondary structural and functional endpoints including OCT-measured drusen volume, dark adaptation, and low-luminance best-corrected visual acuity. Safety and tolerability of oral dapagliflozin in this population are monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with non-foveal geographic atrophy from dry AMD (total GA area 2.5–17.5 mm², at least one lesion ≥1.25 mm² if multifocal), BCVA between 20/25 and 20/320, and treatment-naïve for AMD aside from oral supplements.
Not a fit: Patients with foveal-involving GA, lesion sizes outside the entry range, prior AMD treatments, or other advanced ocular comorbidities are unlikely to benefit from this intervention in this study.
Why it matters
Potential benefit: If successful, this could slow GA lesion growth and help preserve vision-related function in people with dry AMD.
How similar studies have performed: Repurposing SGLT2 inhibitors for GA is a novel clinical approach—SGLT2 drugs have established systemic benefits in diabetes and cardiorenal disease, but there is minimal clinical evidence proving benefit for geographic atrophy to date.
Eligibility criteria
Show full inclusion / exclusion 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 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 9. Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins or mineral 10. Any intraocular surgery or thermal laser within 3 months of date of randomization 11. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks 12. Any prior thermal laser in the macular region, regardless of indication (self-report) 13. Any evidence of choroidal neovascularization in study eye 14. Enrollment in another interventional trial during the trial period
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Rajendra S Apte, MD PhD — Washington University School of Medicine
- Study coordinator: Eve Adcock
- Email: adcockl@wustl.edu
- Phone: 314-286-2946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.