Dapagliflozin (an SGLT2 inhibitor) for slowing geographic atrophy in dry AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met

   1. The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits
   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 in study eye, 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

   1. Any prior intravitreal treatment for any indication in the study eye.
   2. Prior intravitreal treatment (steroids, anti-VEGF) in the fellow eye is permitted if all injections occurred more than 6 months prior to screening, provided the participant has no active intravitreal treatment in either eye at screening or during the study period
   3. Prior exposure to complement inhibitor therapy for retinal disease in either eye at any time remains exclusionary
9. Any intraocular surgery or thermal laser within 3 months of date of randomization
10. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks
11. Any prior thermal laser in the macular region, regardless of indication (self-report)
12. Any evidence of choroidal neovascularization in study eye
13. Enrollment in another interventional trial during the trial period

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a stem cell treatment for geographic atrophy from dry age-related macular degeneration.

  This study is testing a new stem cell treatment for people with geographic atrophy from dry age-related macular degeneration to see if it can help improve their vision.

  Recruiting at 3 sites Phase 1/2 Eyestem Research Pvt. Ltd. · Jālna, Maharashtra and 2 other locations · NCT06394232

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• See if STL303 helps adults with geographic atrophy from AMD

  This study tests STL303 versus placebo in people 60 and older who have geographic atrophy due to age-related macular degeneration to see if it is safe and can help their vision.

  Recruiting at 3 sites Phase 2 Sitala Bio LTD · Bakersfield, California and 55 other locations · NCT07606365

• C.001 for retinal degeneration: a first-in-human dose-escalation safety test

  A first-in-human study will test the safety and tolerability of a single subretinal injection of C.001 in adults with retinal diseases involving retinal pigment epithelium degeneration.

  Recruiting at 2 sites Phase 1 Cellio Therapeutics Inc · Beverly Hills, California and 2 other locations · NCT07594236

• Central microperimetry and radial OCT in geographic atrophy

  We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07556406

• Hyperspectral imaging to map retinal and optic nerve structures

  This study will test whether hyperspectral retinal imaging can detect disease-related features in adults with diabetic retinopathy, glaucoma, age-related macular degeneration, and in healthy volunteers.

  Recruiting Center for Eye Research Australia · Melbourne, Victoria · NCT07555574

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.