SGLT2 Inhibitors for Age-Related Macular Degeneration

Overseen By Eve Adcock

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: SGLT2 inhibitors

Disqualifiers: Diabetes, Heart failure, Renal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dapagliflozin, a medication typically used for diabetes, to determine its potential benefits for individuals with advanced dry age-related macular degeneration (AMD) that leads to vision loss. Researchers aim to assess the drug's safety and effectiveness in slowing retinal damage caused by geographic atrophy (GA), an advanced form of AMD. Participants will receive either dapagliflozin or a placebo (an inactive substance) for one year. Suitable candidates have dry AMD with specific retinal damage and have not yet received other treatments for AMD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have used any investigational drugs in the past 60 days or other SGLT2 inhibitors. You also cannot have had any prior treatment for AMD, except for oral supplements.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that SGLT2 inhibitors, such as dapagliflozin, are usually well-tolerated by patients. In studies involving individuals with type 2 diabetes, participants taking SGLT2 inhibitors reported a lower risk of eye problems, including age-related macular degeneration, which can lead to vision loss. This suggests these medications might help protect the eyes.

However, while these findings are encouraging, they do not guarantee safety for everyone. Some individuals might experience side effects, such as urinary tract infections or dehydration, but these can often be managed with a doctor's assistance.

Prospective trial participants should discuss potential risks and benefits with their doctor. This consultation can help determine if the treatment is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

Unlike the standard care for age-related macular degeneration, which typically includes options like anti-VEGF injections and laser therapies, dapagliflozin offers a novel approach by targeting glucose transport in the eyes. Dapagliflozin is an SGLT2 inhibitor, commonly used to manage diabetes, but researchers are excited because it may also help reduce inflammation and oxidative stress in the retina, which are key factors in macular degeneration. This unique mechanism of action could potentially slow down disease progression and offer a new pathway for treatment beyond the conventional methods.

What evidence suggests that dapagliflozin might be an effective treatment for geographic atrophy?

This trial will compare dapagliflozin with a placebo to evaluate its potential benefits for eye health. Research has shown that dapagliflozin, a type of medication, may protect the eyes from nerve and blood vessel problems. It appears particularly beneficial for the retina, which is crucial for vision. This suggests dapagliflozin might slow retinal damage caused by conditions like Geographic Atrophy (GA) from age-related macular degeneration (AMD). Although more studies are needed to confirm these effects in people, these early findings offer hope for its potential in treating eye conditions like GA in AMD. ^{1 2 3 6 7}

Who Is on the Research Team?

Rajendra S Apte, MD PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with Geographic Atrophy (GA), an advanced stage of dry Age-Related Macular Degeneration (AMD) that leads to progressive retinal cell degeneration. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

BCVA between 20/25 and 20/320

I am 50 years old or older.

Exclusion Criteria

Prior investigational drug use within 60 days

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dapagliflozin 10 mg or a matching placebo daily for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview The study is testing the safety, tolerability, and effectiveness of SGLT2 inhibitors like Dapagliflozin in treating GA associated with AMD. Participants will either receive the actual medication or a matching placebo to compare outcomes.

How Is the Trial Designed?

Group I: Dapagliflozin 10 mg daily for 12 months Experimental Treatment 1 Intervention

Dapagliflozin 10 mg daily PO for 12 consecutive months

Group II: Matching Placebo for 12 months Placebo Group 1 Intervention

Subjects will receive a placebo medication daily PO for 12 consecutive months

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020956/

Use of SGLT2 Inhibitors Versus DPP-4 Inhibitors and Age ... Second, we focused on specific outcomes such as AMD, dry AMD, and ... aging and age-related macular degeneration. Prog Retin Eye Res. 2001 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07174687

NCT07174687 | SGLT2 Inhibitors in Geographic Atrophy ... and efficacy of oral dapagliflozin in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study will randomize ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9114950/

Dapagliflozin protects neural and vascular dysfunction of the ... While DR is mainly a disease of vascular dysfunction, changes in the neural retina precede vascular changes. DR exhibits changes in retinal b- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0039625725000190

An update on ocular effects of antidiabetic medications Further research has explored metformin's role in reducing age-related macular degeneration (AMD) incidence and progression. A large study found that metformin ...

5. ajmc.com ajmc.com/view/diabetes-drug-farxiga-cuts-heart-risks-in-topline-results

Diabetes Drug Farxiga Cuts Heart Risks in Topline Results ... Data-Driven Insights and Innovations to Enhance AMD and ... Age-Related Macular Degeneration and Diabetic Macular Edema: Optimizing Outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11379725/

Association between sodium–glucose cotransporter-2 (SGLT2 ... SGLT2 inhibitor may have a better chance to propone macular degeneration disease process and lead to the protecting effect. However, additional clinical and ...

7. researchgate.net researchgate.net/publication/390981193_Use_of_SGLT2_Inhibitors_Versus_DPP-4_Inhibitors_and_Age-Related_Macular_Degeneration_in_Patients_WithType_2_Diabetes_A_Multinational_Cohort_Study

(PDF) Use of SGLT2 Inhibitors Versus DPP-4 ... Conclusions: In patients with T2DM, those prescribed SGLT2 inhibitors may experience lower risks of AMD and dry AMD compared to those prescribed ...