AzTrials
AzTrials

Retinal DegenerationPhase 2NCT07174687

SGLT2 Inhibitors in Geographic Atrophy

A Phase 2 study testing Dapagliflozin in people with Retinal Degeneration and Retinal Diseases, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
2 Dec 2025to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met
  • The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits
Show all 10Show fewer
  • 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 in study eye, except for oral supplements

Who cannot join

  • 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
Show all 16Show fewer
  • 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 intravitreal treatment for any indication in the study eye.
  • 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
  • Prior exposure to complement inhibitor therapy for retinal disease in either eye at any time remains exclusionary
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eve Adcock contact

314-286-2946

adcockl@wustl.edu

United States1 site, 1 recruiting

  • Washington University

    St Louis, Missouri, 63110

    Eve Adcock, 314-286-2946, adcockl@wustl.edu

    Rajendra S Apte, MD PhD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

This is a Phase II, prospective, single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of oral dapagliflozin in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The study will randomize approximately 70 subjects to obtain at least 60 evaluable subjects at a single center site.

Subjects will be randomized in a 1:1 manner to receive:

  1. Dapagliflozin 10 mg (oral) once daily
  2. Matching placebo (oral) once daily

Primary outcome of interest will be progression of GA lesion area over the 1-year period measured by fundus autofluorescence (FAF) , and secondary outcomes include structural and functional testing for visual function such as change in drusen volume as measured by OCT, dark adaptation, and low luminance BCVA to determine the effect of dapagliflozin on the progression of dry AMD.

All subjects will return for a final follow-up visit at Month 12, marking the conclusion of the study.

Being tested
Dapagliflozin, Matching Placebo
Keywords
Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, SGLT2, Dapagliflozin
Medical subject headings
Retinal Degeneration, Retinal Diseases, Eye Diseases, Geographic Atrophy, Pathological Conditions, Anatomical, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Farxiga

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

  • Matching PlaceboOther

    Matching oral placebo to dapagliflozin

Study groups in NCT07174687
Study groupRoleWhat they receive
Dapagliflozin 10 mg daily for 12 monthsExperimentalDapagliflozin 10 mg daily PO for 12 consecutive months
Receives: Drug: Dapagliflozin
Matching Placebo for 12 monthsPlacebo comparatorSubjects will receive a placebo medication daily PO for 12 consecutive months
Receives: Other: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (screening) and Month 12.

Secondary outcomes (4)

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

    The mean change in size of drusen volume measured by OCT from Baseline to Month 12

    Measured: Baseline (screening) and Month 12.

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

    The mean change in best corrected visual acuity (ETDRS letters) from Baseline to Month 12

    Measured: Baseline (screening) and Month 12.

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

    The mean change in rod intercept time on dark adaptation from Baseline to Month 12

    Measured: Baseline (screening) and Month 12.

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

    The mean change in low luminance best corrected visual acuity (ETDRS letters) from Baseline to Month 12

    Measured: Baseline (screening) and Month 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start2 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174687
Sponsor's protocol ID
202507116
Status last verified
Dec 2025
First submitted
5 Sep 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the study team due to the small sample size and the associated risk of re-identification in this single-site pilot trial. In place of IPD sharing, de-identified, aggregate results will be disseminated through peer-reviewed publications and presentations, and summary-level data may be made available upon reasonable request.

Publications

  • Yao S, Zheng F, Yu Y, Zhan Y, Xu N, Luo G, Zheng L. Apolipoprotein M promotes cholesterol uptake and efflux from mouse macrophages. FEBS Open Bio. 2021 Jun;11(6):1607-1620. doi: 10.1002/2211-5463.13157. Epub 2021 May 2.

    PubMed 33830664

  • Wolfrum C, Poy MN, Stoffel M. Apolipoprotein M is required for prebeta-HDL formation and cholesterol efflux to HDL and protects against atherosclerosis. Nat Med. 2005 Apr;11(4):418-22. doi: 10.1038/nm1211. Epub 2005 Mar 27.

    PubMed 15793583

  • Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

    PubMed 30415602

  • Sunness JS, Gonzalez-Baron J, Applegate CA, Bressler NM, Tian Y, Hawkins B, Barron Y, Bergman A. Enlargement of atrophy and visual acuity loss in the geographic atrophy form of age-related macular degeneration. Ophthalmology. 1999 Sep;106(9):1768-79. doi: 10.1016/S0161-6420(99)90340-8.

    PubMed 10485549

  • Solini A, Giannini L, Seghieri M, Vitolo E, Taddei S, Ghiadoni L, Bruno RM. Dapagliflozin acutely improves endothelial dysfunction, reduces aortic stiffness and renal resistive index in type 2 diabetic patients: a pilot study. Cardiovasc Diabetol. 2017 Oct 23;16(1):138. doi: 10.1186/s12933-017-0621-8.

    PubMed 29061124

  • Schatz H, McDonald HR. Atrophic macular degeneration. Rate of spread of geographic atrophy and visual loss. Ophthalmology. 1989 Oct;96(10):1541-51. doi: 10.1016/s0161-6420(89)32694-7.

    PubMed 2587050

  • Sarks JP, Sarks SH, Killingsworth MC. Evolution of geographic atrophy of the retinal pigment epithelium. Eye (Lond). 1988;2 ( Pt 5):552-77. doi: 10.1038/eye.1988.106.

    PubMed 2476333

  • Ruiz M, Okada H, Dahlback B. HDL-associated ApoM is anti-apoptotic by delivering sphingosine 1-phosphate to S1P1 & S1P3 receptors on vascular endothelium. Lipids Health Dis. 2017 Feb 8;16(1):36. doi: 10.1186/s12944-017-0429-2.

    PubMed 28179022

  • Potter JW, Thallemer JM. Geographic atrophy of the retinal pigment epithelium: diagnosis and vision rehabilitation. J Am Optom Assoc. 1981 Jun;52(6):503-8.

    PubMed 7264141

  • Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

    PubMed 30990260

  • McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

    PubMed 31535829

  • Maguire P, Vine AK. Geographic atrophy of the retinal pigment epithelium. Am J Ophthalmol. 1986 Nov 15;102(5):621-5. doi: 10.1016/0002-9394(86)90535-0.

    PubMed 3777083

  • Maayah ZH, Ferdaoussi M, Takahara S, Soni S, Dyck JRB. Empagliflozin suppresses inflammation and protects against acute septic renal injury. Inflammopharmacology. 2021 Feb;29(1):269-279. doi: 10.1007/s10787-020-00732-4. Epub 2020 Jun 20.

    PubMed 32564182

  • Leibowitz HM, Krueger DE, Maunder LR, Milton RC, Kini MM, Kahn HA, Nickerson RJ, Pool J, Colton TL, Ganley JP, Loewenstein JI, Dawber TR. The Framingham Eye Study monograph: An ophthalmological and epidemiological study of cataract, glaucoma, diabetic retinopathy, macular degeneration, and visual acuity in a general population of 2631 adults, 1973-1975. Surv Ophthalmol. 1980 May-Jun;24(Suppl):335-610.

    PubMed 7444756

  • Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5.

    PubMed 23668478

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin in people with Retinal Degeneration and Retinal Diseases, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eve Adcock (314-286-2946, adcockl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12 (time frame: Baseline (screening) and Month 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174687, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in