RECRUITINGPhase 2INTERVENTIONAL
SGLT2 Inhibitors in Geographic Atrophy
Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Capable of giving signed willing to sign a consent form, 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
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 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:
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
Treatments Being Tested
DRUG
Dapagliflozin
Dapagliflozin is an SGLT2 inhibitor used in diabetes, heart failure, and chronic kidney disease patients.
OTHER
Matching Placebo
Matching oral placebo to dapagliflozin
Locations (1)
Washington University
St Louis, Missouri, United States