NCT07174687 SGLT2 Inhibitors in Geographic Atrophy
| NCT ID | NCT07174687 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Washington University School of Medicine |
| Condition | Retinal Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-12-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Rajendra S Apte, MD PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07174687 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Retinal Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07174687 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07174687 currently recruiting?
Yes, NCT07174687 is actively recruiting participants. Contact the research team at adcockl@wustl.edu for enrollment information.
Where is the NCT07174687 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07174687 clinical trial?
NCT07174687 is sponsored by Washington University School of Medicine. The principal investigator is Rajendra S Apte, MD PhD at Washington University School of Medicine. The trial plans to enroll 70 participants.