What side effects are associated with this type of intervention?

The most common side effects of PDE5 inhibitors, such as Sildenafil, used in the treatment of Choroidal Ischemia include headaches, flushing, dyspepsia, nasal congestion, and visual disturbances. These visual disturbances can include changes in color vision, blurred vision, and increased sensitivity to light. Less commonly, patients may experience dizziness, back pain, and muscle aches. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits of treatment outweigh the risks.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for choroidal ischemia that are directly analogous to Sildenafil (a PDE5 inhibitor). Sildenafil is primarily approved for erectile dysfunction and pulmonary arterial hypertension due to its vasodilatory effects. However, its potential benefits for choroidal and retinal conditions are being explored in clinical trials. Other treatments for related retinal and choroidal conditions often focus on anti-VEGF therapies, which target vascular endothelial growth factors to manage neovascularization and improve blood flow in diseases like age-related macular degeneration.

What other types of research exist?

Promising alternatives to Sildenafil for Choroidal Ischemia may include other PDE5 inhibitors such as Tadalafil, which has shown potential in improving cerebral blood flow and endothelial function. Additionally, exploring treatments that protect endothelial cells and enhance vasodilation, such as those used in pulmonary hypertension or small-vessel occlusion stroke, could be beneficial.

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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 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.

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.

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).

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

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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:

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I have heart disease and need nitrates.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 3Eligibility criteria met

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.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,471 Previous Clinical Trials

2,536,325 Total Patients Enrolled

Donald Jackson Coleman, MDPrincipal InvestigatorColumbia University

~0 spots leftby Dec 2024

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