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Sildenafil for Treatment of Choroidal Ischemia

NCT04356716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-04

Study results available
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Summary

The hypothesis of this study is to determine if there is a benefit afforded by the use of systemic Sildenafil to patients with choroidal and retinal degenerations and dystrophies, such as vitelliform degeneration, dry and reticular age-related macular degeneration (AMD) as well as patients with hereditary and acquired retinal dystrophies such as retinitis pigmentosa and central serous retinopathy.

Conditions

  • Choroidal Ischemia
  • Vitelliform Macular Dystrophy
  • Age-related Macular Degeneration
  • Central Serous Retinopathy
  • Retinitis Pigmentosa

Interventions

DRUG

Sildenafil

Initial Sildenafil dosage will be weight dependent. Participants will start at 40 mg daily (20mg in the morning, 20 mg in the evening) or 60 mg daily (40mg in the morning and 20 mg in the evening). Sildenafil dosage may be increased to up to 80mg daily (20-40mg in the morning and 20-40mg in the evening) based on the response to lower doses. If the participant has not had improvement after initial treatment, the dose may be increased, at the discretion of the study physician.

OTHER

Standard of Care Sildenafil

Medical record review of participants that receive Sildenafil as part of standard of care.

DIAGNOSTIC_TEST

Ocular Coherence Tomography-Angiography (OCT-A)

Retinal photographs will be taken at each study visit.

OTHER

Visual Acuity (VA)

Visual acuity will be measured with Snellen Eye Chart at each study visit.

Sponsors & Collaborators

Principal Investigators

  • Donald Jackson Coleman, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-11
Primary Completion
2020-02-18
Completion
2020-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356716 on ClinicalTrials.gov