Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2025-12-02
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dapagliflozin 10 mg daily for 12 months
Dapagliflozin 10 mg daily PO for 12 consecutive months
Dapagliflozin
Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
Matching Placebo for 12 months
Subjects will receive a placebo medication daily PO for 12 consecutive months
Matching Placebo
Matching oral placebo to dapagliflozin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Matching Placebo
Matching oral placebo to dapagliflozin
Dapagliflozin
Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 with the presence of non-foveal Geographic Atrophy (GA)
1. The geographic atrophy must not involve the center point of the fovea.
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, except for oral supplements
Exclusion Criteria
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
9. 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
10. Any intraocular surgery or thermal laser within 3 months of date of randomization
11. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks
12. Any prior thermal laser in the macular region, regardless of indication (self-report)
13. Any evidence of choroidal neovascularization in study eye
14. Enrollment in another interventional trial during the trial period
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rajendra S. Apte
Principal Investigator; Paul A. Cibis Distinguished Professor of Ophthalmology and Visual Sciences; Vice Chair for Innovation and Translation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rajendra S Apte, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eve Adcock
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Demaria R, Picard E, Bodino M, Aymard T, Albat B, Frapier JM, Chaptal PA. [Migration of a clavicular bone wire acutely perforating the ascending aorta]. Presse Med. 1998 Jun 13;27(21):1013. No abstract available. French.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Kosiborod M, Gause-Nilsson I, Xu J, Sonesson C, Johnsson E. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and concomitant heart failure. J Diabetes Complications. 2017 Jul;31(7):1215-1221. doi: 10.1016/j.jdiacomp.2017.02.001. Epub 2017 Feb 10.
Kohler S, Zeller C, Iliev H, Kaspers S. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials. Adv Ther. 2017 Jul;34(7):1707-1726. doi: 10.1007/s12325-017-0573-0. Epub 2017 Jun 19.
Kim SR, Lee SG, Kim SH, Kim JH, Choi E, Cho W, Rim JH, Hwang I, Lee CJ, Lee M, Oh CM, Jeon JY, Gee HY, Kim JH, Lee BW, Kang ES, Cha BS, Lee MS, Yu JW, Cho JW, Kim JS, Lee YH. SGLT2 inhibition modulates NLRP3 inflammasome activity via ketones and insulin in diabetes with cardiovascular disease. Nat Commun. 2020 May 1;11(1):2127. doi: 10.1038/s41467-020-15983-6.
Holz FG, Strauss EC, Schmitz-Valckenberg S, van Lookeren Campagne M. Geographic atrophy: clinical features and potential therapeutic approaches. Ophthalmology. 2014 May;121(5):1079-91. doi: 10.1016/j.ophtha.2013.11.023. Epub 2014 Jan 14.
Guo Z, Javaheri A. Empagliflozin to Prevent Doxorubicin Cardiotoxicity. JACC CardioOncol. 2025 Feb;7(2):185-187. doi: 10.1016/j.jaccao.2025.01.005.
Guo Z, Valenzuela Ripoll C, Picataggi A, Rawnsley DR, Ozcan M, Chirinos JA, Chendamarai E, Girardi A, Riehl T, Evie H, Diab A, Kovacs A, Hyrc K, Ma X, Asnani A, Shewale SV, Scherrer-Crosbie M, Cowart LA, Parks JS, Zhao L, Gordon D, Ramirez-Valle F, Margulies KB, Cappola TP, Desai AA, Pedersen LN, Bergom C, Stitziel NO, Rettig MP, DiPersio JF, Hajny S, Christoffersen C, Diwan A, Javaheri A. Apolipoprotein M Attenuates Anthracycline Cardiotoxicity and Lysosomal Injury. JACC Basic Transl Sci. 2023 Jan 4;8(3):340-355. doi: 10.1016/j.jacbts.2022.09.010. eCollection 2023 Mar.
Dudka LT, Inglis HJ, Johnson RE, Pechinski JM, Plowman S. Inequality of inspired and expired gaseous nitrogen in man. Nature. 1971 Jul 23;232(5308):265-8. doi: 10.1038/232265b0. No abstract available.
Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057.
Feuer WJ, Yehoshua Z, Gregori G, Penha FM, Chew EY, Ferris FL, Clemons TE, Lindblad AS, Rosenfeld PJ. Square root transformation of geographic atrophy area measurements to eliminate dependence of growth rates on baseline lesion measurements: a reanalysis of age-related eye disease study report no. 26. JAMA Ophthalmol. 2013 Jan;131(1):110-1. doi: 10.1001/jamaophthalmol.2013.572. No abstract available.
Elsoe S, Ahnstrom J, Christoffersen C, Hoofnagle AN, Plomgaard P, Heinecke JW, Binder CJ, Bjorkbacka H, Dahlback B, Nielsen LB. Apolipoprotein M binds oxidized phospholipids and increases the antioxidant effect of HDL. Atherosclerosis. 2012 Mar;221(1):91-7. doi: 10.1016/j.atherosclerosis.2011.11.031. Epub 2011 Nov 27.
Christoffersen C, Obinata H, Kumaraswamy SB, Galvani S, Ahnstrom J, Sevvana M, Egerer-Sieber C, Muller YA, Hla T, Nielsen LB, Dahlback B. Endothelium-protective sphingosine-1-phosphate provided by HDL-associated apolipoprotein M. Proc Natl Acad Sci U S A. 2011 Jun 7;108(23):9613-8. doi: 10.1073/pnas.1103187108. Epub 2011 May 23.
Christoffersen C, Jauhiainen M, Moser M, Porse B, Ehnholm C, Boesl M, Dahlback B, Nielsen LB. Effect of apolipoprotein M on high density lipoprotein metabolism and atherosclerosis in low density lipoprotein receptor knock-out mice. J Biol Chem. 2008 Jan 25;283(4):1839-47. doi: 10.1074/jbc.M704576200. Epub 2007 Nov 15.
Christensen PM, Liu CH, Swendeman SL, Obinata H, Qvortrup K, Nielsen LB, Hla T, Di Lorenzo A, Christoffersen C. Impaired endothelial barrier function in apolipoprotein M-deficient mice is dependent on sphingosine-1-phosphate receptor 1. FASEB J. 2016 Jun;30(6):2351-9. doi: 10.1096/fj.201500064. Epub 2016 Mar 8.
Bonnet F, Scheen AJ. Effects of SGLT2 inhibitors on systemic and tissue low-grade inflammation: The potential contribution to diabetes complications and cardiovascular disease. Diabetes Metab. 2018 Dec;44(6):457-464. doi: 10.1016/j.diabet.2018.09.005. Epub 2018 Sep 26.
Apte RS. Age-Related Macular Degeneration. N Engl J Med. 2021 Aug 5;385(6):539-547. doi: 10.1056/NEJMcp2102061.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202507116
Identifier Type: -
Identifier Source: org_study_id