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New treatment option for Retinal Degeneration
Official title SGLT2 Inhibitors in Geographic Atrophy
ClinicalTrials.gov ID: NCT07174687
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for retinal degeneration.
Also referred to as Farxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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 with the presence of non-foveal Geographic Atrophy (GA)
You likely can't join if
- 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
See the full eligibility criteria
- 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 with the presence of non-foveal Geographic Atrophy (GA)
- The geographic atrophy must not involve the center point of the fovea.
- 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, except for oral supplements
- 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
- 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...
- 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
- 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 treatment trial during the trial period
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.