Sildenafil for Choroidal Ischemia

Recruiting in Palo Alto (17 mi)

Overseen by Donald Jackson Coleman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if Sildenafil can help patients with certain eye conditions by improving blood flow in the eye. The goal is to slow down vision loss and reduce the need for frequent treatments. Sildenafil, commonly known as Viagra, is primarily used to treat erectile dysfunction but has been studied for its effects on ocular blood flow and potential neuroprotective benefits in various eye conditions.

Eligibility Criteria

This trial is for people with certain eye conditions like dry and reticular age-related macular degeneration, retinitis pigmentosa, central serous retinopathy, or similar disorders. Participants must be able to attend monthly or bi-monthly exams. Those with heart disease needing nitrates can't join.

Inclusion Criteria

I have a diagnosed retinal or choroidal condition, like AMD or retinitis pigmentosa.

Exclusion Criteria

I have heart disease and need nitrates.

I cannot attend monthly or every other month check-ups.

Participant Groups

The study tests if Sildenafil (known for treating erectile dysfunction) helps patients with choroidal and retinal issues by comparing it to standard care. It includes regular eye scans (OCT-A) and vision checks (VA).

Group I: Standard of Care Sildenafil Active Control 1 Intervention

Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.

Group II: Sildenafil Active Control 3 Interventions

Participants are prescribed sildenafil 40-80 mg daily.

Sildenafil is already approved in United States, European Union, United States, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Viagra for:

• Erectile dysfunction
• Pulmonary arterial hypertension

🇪🇺 Approved in European Union as Viagra for:

• Erectile dysfunction
• Pulmonary arterial hypertension

🇺🇸 Approved in United States as Revatio for:

• Pulmonary arterial hypertension

🇨🇦 Approved in Canada as Sildenafil for:

• Erectile dysfunction
• Pulmonary arterial hypertension

🇯🇵 Approved in Japan as Sildenafil for:

• Erectile dysfunction
• Pulmonary arterial hypertension

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center, Edward Harkness Eye Institute New York, NY

Who Is Running the Clinical Trial?

Columbia University Lead Sponsor

References