SGLT2 Inhibitors in Geographic Atrophy

NCT07174687 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202507116
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12

  The square root GA lesion size (i.e. transformed area of GA) was measured by FAF photographs at baseline and 12 months. Baseline is defined as the last available, non-missing observation prior to first study drug administration.

  Baseline (screening) and Month 12.

Secondary Outcomes (4)

• Mean Change From Baseline in Drusen Size in the Study Eye at Month 12

  Baseline (screening) and Month 12.

• Mean Change From Baseline in best corrected visual acuity (ETDRS letters) from Baseline to Month 12

  Baseline (screening) and Month 12.

• Mean Change From Baseline in Dark Adaptation in the Study Eye at Month 12

  Baseline (screening) and Month 12.

• Mean Change From Baseline in low luminance best corrected visual acuity (ETDRS letters) from Baseline to Month 12

  Baseline (screening) and Month 12.

Study Arms (2)

Dapagliflozin 10 mg daily for 12 months

EXPERIMENTAL

Dapagliflozin 10 mg daily PO for 12 consecutive months

Drug: Dapagliflozin

Matching Placebo for 12 months

PLACEBO COMPARATOR

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

Other: Matching Placebo

Interventions

Dapagliflozin DRUG

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

Also known as: Farxiga

Dapagliflozin 10 mg daily for 12 months

Matching Placebo OTHER

Matching oral placebo to dapagliflozin

Matching Placebo for 12 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior investigational drug use within 60 days
• Use of other SGLT2 inhibitors
• 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
• 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 treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins or mineral
• Any intraocular surgery or thermal laser within 3 months of date of randomization
• Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks
• Any prior thermal laser in the macular region, regardless of indication (self-report)
• Any evidence of choroidal neovascularization in study eye
• Enrollment in another interventional trial during the trial period

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

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MeSH Terms

Conditions

Retinal Degeneration; Retinal Diseases; Eye Diseases; Geographic Atrophy; Pathological Conditions, Anatomical; Macular Degeneration

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajendra S Apte, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eve Adcock

CONTACT

314-286-2946; adcockl@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Paul A. Cibis Distinguished Professor of Ophthalmology and Visual Sciences; Vice Chair for Innovation and Translation

Model Details: Participants will be randomized 1:1 to either dapagliflozin or placebo and followed concurrently for 12 months. Two arms are defined: Experimental (Dapagliflozin 10 mg PO daily) and Placebo Comparator (matching placebo PO daily), with identical visit schedules for imaging and safety monitoring.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)