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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.

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

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,806 Total Patients Enrolled

Donald Jackson Coleman, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some potential risks associated with taking Sildenafil?

"While there is some evidence from Phase 2 clinical trials that suggests Standard of Care Sildenafil is safe, there is no data to support its efficacy."

Answered by AI

How many people are being recruited for this clinical trial?

"That is accurate. The clinical trial mentioned is recruiting patients, as indicated by information found on clinicaltrials.gov. This specific research project was first posted on November 11th, 2014 and the most recent update was on May 2nd, 20212. They are seeking 25 individuals to participate at 1 location."

Answered by AI

Are people currently being accepted into this experiment?

"That is accurate. The listing on clinicaltrials.gov makes it clear that this study is looking for patients right now. This particular trial was posted on November 11th, 2014 and updated May 2nd, 2022. They are hoping to enroll 25 people total from 1 location."

Answered by AI

What medical ailment does Standard of Care Sildenafil usually treat?

"Sildenafil, which is the Standard of Care for treating premature ejaculation, nyha functional class ii-iii pulmonary arterial hypertension, and pulmonary arterial hypertension."

Answered by AI

Recent research and studies

OphthalmologicaJournal

Treatment of Macular Degeneration with Sildenafil: Results of a Two-year Trial

Coleman, D. Jackson, Winston Lee, Stanley Chang, Ronald H. Silverman, Harriet O. Lloyd, Suzanne Daly, and Stephen H. Tsang. 2018. “Treatment of Macular Degeneration with Sildenafil: Results of a Two-year Trial”. Ophthalmologica. S. Karger AG. doi:10.1159/000486105.

British Journal of OphthalmologyJournal

Coleman, D Jackson, Ronald H Silverman, Mark J Rondeau, Harriet O Lloyd, Aziz A Khanifar, and R V Paul Chan. 2013. “Age-related Macular Degeneration: Choroidal Ischaemia?”. British Journal of Ophthalmology. BMJ. doi:10.1136/bjophthalmol-2013-303143.

British Journal of OphthalmologyJournal

clinicaltrials.govStudy

Sildenafil for Treatment of Choroidal Ischemia

Donald Coleman 2014. "Sildenafil for Treatment of Choroidal Ischemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04356716.

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