What is dapagliflozin studying for geographic atrophy related to age-related macular degeneration?

Dapagliflozin is being studied to understand its safety, tolerability, and possible effects on the progression of geographic atrophy, an advanced form of dry AMD. This research aims to evaluate whether this oral medication can influence retinal changes in affected adults. The study is sponsored by Washington University School of Medicine and involves detailed eye assessments over one year.

Who may be eligible for this geographic atrophy clinical trial?

Adults 50 years or older with dry advanced AMD and non-foveal geographic atrophy may be eligible. Both males and females who are surgically sterilized or amenorrheic for at least one year can participate. Important factors include no prior AMD treatment except supplements and no diabetes. Please review eligibility criteria for more details.

Is there any cost to participate in this geographic atrophy clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs associated with attending study visits.

Actively Recruiting

Phase 2

Age: 50Years +

All Genders

ID07174687

Study of Oral Dapagliflozin for Slowing Geographic Atrophy Progression in Age-Related Macular Degeneration

Led by Washington University School of Medicine · Updated on 2025-12-18

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and potential activity of SGLT2 inhibitors in people with Geographic Atrophy GA, an advanced stage of dry age-related macular degeneration AMD that causes progressive retinal cell loss. This Phase II study focuses on adults aged 50 and older, aiming to understand how dapagliflozin might affect the progression of GA related to AMD. The study is a randomized, double-blind, placebo-controlled trial conducted at a single center. About 70 participants will be randomly assigned to receive either 10 mg of oral dapagliflozin daily or a matching placebo for 12 months. The main goal is to measure changes in GA lesion size over one year, with additional tests assessing changes in drusen volume, dark adaptation, and visual acuity. Participants will have baseline assessments and then return for regular follow-up visits, including a final visit at month 12. Researchers will use imaging methods like fundus autofluorescence and OCT to track GA progression, along with vision tests. Safety and tolerability will be closely monitored throughout the study to evaluate the impact of dapagliflozin on dry AMD progression.

CONDITIONS

Brief Title

SGLT2 Inhibitors in Geographic Atrophy

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Dapagliflozin (10 mg, oral, daily)	Placebo (matching oral tablet, daily)
What is it?	An oral SGLT2 inhibitor, typically used in diabetes and heart disease, being investigated for its potential to slow geographic atrophy in dry AMD.	A daily oral placebo designed to match the dapagliflozin tablet for appearance and schedule, containing no active medication.
Role in the trial	Tested as the investigational approach for participants with non-foveal geographic atrophy from dry AMD.	Serves as a control group to allow evaluation of dapagliflozin's effect on geographic atrophy.
Primary use	Studied to assess if it can reduce the growth of non-foveal GA lesions in patients with dry AMD over 12 months.	Used as a comparison to measure natural GA disease progression and to control for non-drug effects.
How is it given or performed?	Oral tablet taken once daily for one year.	Oral placebo tablet, identical appearance, taken daily for one year.
What is the current evidence?	There is no established evidence for dapagliflozin in geographic atrophy. The effect is under clinical investigation.	There are currently no approved pharmacologic treatments for non-foveal GA; participants receive placebo to track the natural course of disease.
Important limitations	Dapagliflozin's effects on GA are not established; results for visual outcomes and lesion progression will depend on trial completion. The trial only includes non-foveal GA, and participants with other eye conditions or diabetes are excluded, so findings may not apply more broadly.	Placebo does not change geographic atrophy itself; it provides a control to measure typical GA progression but offers no clinical benefit.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 50Years +

All Genders

Eligibility Criteria

You may qualify if you...

Able to give signed informed consent and comply with study requirements
Willing and reliable to complete the study procedures and attend all visits
Male or female who is surgically sterilized or amenorrheic for at least one year
50 years of age or older
Diagnosis of dry advanced AMD with non-foveal geographic atrophy
Geographic atrophy area between 2.5 mm2 and 17.5 mm2, with at least one lesion 1.25 mm2 or larger if multiple lesions
Best corrected visual acuity between 20/25 and 20/320
No prior treatment for AMD except oral supplements

You will not qualify if you...

Use of any investigational drug within 60 days prior to study
Current use of other SGLT2 inhibitors
History or presence of symptomatic hypotension or low blood pressure below 90 mmHg
Diagnosis of Type I or Type II diabetes mellitus
End stage renal disease or severely reduced kidney function (eGFR less than 25 mL/min/1.73 m2)
History of heart failure
Serious allergic reaction to dapagliflozin or its ingredients
Other medical or psychiatric conditions that interfere with study compliance
Any prior AMD treatment other than oral supplements
Intraocular surgery or laser treatment within 3 months before randomization
Recent ocular or periocular infection or inflammation within 12 weeks
Prior thermal laser treatment in the macular area
Evidence of abnormal new blood vessels in the study eye
Participation in another interventional clinical trial during this study period

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive either dapagliflozin 10 mg or a matching placebo orally once daily to assess the effect on geographic atrophy secondary to age-related macular degeneration.

Regular visits during the 12 months of treatment

Follow-up

Duration - 1 visit at Month 12

Participants return for a final visit to assess the progression of geographic atrophy and visual function after completing treatment.

1 visit (in-person)