Actively Recruiting

Phase 2
Age: 50Years +
All Genders
ID07174687

Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

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

70

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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)

Trial Site Locations

Total: 1 location

1

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

E

Eve Adcock

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Apolipoprotein M is required for prebeta-HDL formation and cholesterol efflux to HDL and protects against atherosclerosis.

Christian Wolfrum, Matthew N Poy, Markus Stoffel

https://pubmed.ncbi.nlm.nih.gov/15793583

Enlargement of atrophy and visual acuity loss in the geographic atrophy form of age-related macular degeneration.

J S Sunness, J Gonzalez-Baron, C A Applegate...

https://pubmed.ncbi.nlm.nih.gov/10485549

Dapagliflozin acutely improves endothelial dysfunction, reduces aortic stiffness and renal resistive index in type 2 diabetic patients: a pilot study.

Anna Solini, Livia Giannini, Marta Seghieri...

https://pubmed.ncbi.nlm.nih.gov/29061124

HDL-associated ApoM is anti-apoptotic by delivering sphingosine 1-phosphate to S1P1 & S1P3 receptors on vascular endothelium.

Mario Ruiz, Hiromi Okada, Björn Dahlbäck

https://pubmed.ncbi.nlm.nih.gov/28179022