← Back to Search

Phosphodiesterase Type 5 (PDE5) Inhibitor

Sildenafil for Choroidal Ischemia

Phase 2
Waitlist Available
Led By Donald Jackson Coleman, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of retinal and choroidal degenerations (reticular or vitelliform AMD or vitelliform-type subretinal drusen) or hereditary or acquired retinal dystrophies (retinitis pigmentosa or central serous retinopathy)
Be older than 18 years old
Must not have
Diagnosis of heart disease requiring use of nitrates
Inability to be examined monthly or bi-monthly
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test whether Sildenafil can help people with degenerative eye diseases.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, visual disturbances such as blurred vision or blue-tinted sight, nasal congestion, dizziness, and in rare cases serious cardiovascular events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a diagnosed retinal or choroidal condition, like AMD or retinitis pigmentosa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart disease and need nitrates.
Select...
I cannot attend monthly or every other month check-ups.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Choroidal Perfusion

Trial Design

2Treatment groups
Active Control
Group I: Standard of Care SildenafilActive Control1 Intervention
Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.
Group II: SildenafilActive Control3 Interventions
Participants are prescribed sildenafil 40-80 mg daily.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for choroidal ischemia, such as Sildenafil, work by inhibiting phosphodiesterase type-5 (PDE5), which increases levels of cyclic guanosine monophosphate (cGMP). Elevated cGMP leads to vasodilation, improving blood flow to the choroidal and retinal regions. This enhanced blood flow is crucial for choroidal ischemia patients as it helps to restore oxygen and nutrient delivery to the affected tissues, potentially preventing further degeneration and improving visual function.
Nitric oxide in retinal and choroidal blood flow autoregulation in newborn pigs: interactions with prostaglandins.Sildenafil stimulates aqueous humor turnover in rabbits.Complementary therapy for the treatment of glaucoma: a perspective.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,465 Total Patients Enrolled
Donald Jackson Coleman, MDPrincipal InvestigatorColumbia University
~1 spots leftby Dec 2024