RECRUITING

SGLT2 Inhibitors in Geographic Atrophy

Conditions

Retinal Degeneration Retinal Diseases Eye Diseases Geographic Atrophy Pathological Conditions, Anatomical Geographic Atrophy (GA)Age-related Macular Degeneration AMD SGLT2 Dapagliflozin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07174687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	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 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

Inclusion Criteria

Exclusion 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 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

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
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

Contacts and Locations

Study Contact

Eve Adcock

CONTACT

314-286-2946

adcockl@wustl.edu

Principal Investigator

Rajendra S Apte, MD PhD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Rajendra S Apte, MD PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-10

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Geographic Atrophy (GA)
Age-related Macular Degeneration
AMD
SGLT2
Dapagliflozin

Additional Relevant MeSH Terms

Retinal Degeneration
Retinal Diseases
Eye Diseases
Geographic Atrophy
Pathological Conditions, Anatomical