Sildenafil for Treatment of Choroidal Ischemia

Sildenafil for Treatment of Choroidal Ischemia

Sponsors

Lead Sponsor: Columbia University

Source Columbia University
Brief 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.

Detailed Description

Age-Related Macular Degeneration (AMD) is a sight-threatening visual disturbance that affects the macula in older ages. It is irreversible if the pigment epithelium is lost (dry AMD), but wet AMD can be arrested or delayed with the use of intraocular injections of one of 3 different compounds. All three drugs are injected into the eye in minute doses of usually 0.1 ml. These are usually injected at 4 to 6 week intervals and treatment may be extended for several years. Different patterns of injection times are followed but usually are monthly for 12 or more months, or monthly for 3 months and then extended observation at one to two month intervals unless vision (visual acuity) declines or Optical Coherence Tomography-angiography (OCT-A) shows recurrence of fluid or increase in size or amount of drusen (deposits of lipofuscin) in the retina. Vitelliform macular degeneration is a disorder that causes visual loss due to drusen in the macula, which have been shown to be identical to the deposits seen in macular degeneration. The goal of therapy in this proposal is to use sildenafil to increase choroidal blood flow to treat dry AMD and slow the progression of visual loss in vitelliform and age-related dry AMD as well as other macular, retinal and choroidal degenerations and dystrophies, as well as reduce or eliminate the number of injections required by slowing down transformation of dry AMD to wet AMD in treated patients.

Overall Status Recruiting
Start Date November 11, 2014
Completion Date April 2021
Primary Completion Date April 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Choroidal Perfusion Up to 5 Years
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sildenafil

Description: 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.

Arm Group Label: Sildenafil

Intervention Type: Other

Intervention Name: Standard of Care Sildenafil

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

Arm Group Label: Standard of Care Sildenafil

Intervention Type: Diagnostic Test

Intervention Name: Ocular Coherence Tomography-Angiography (OCT-A)

Description: Retinal photographs will be taken at each study visit.

Arm Group Label: Sildenafil

Intervention Type: Other

Intervention Name: Visual Acuity (VA)

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

Arm Group Label: Sildenafil

Eligibility

Criteria:

Inclusion Criteria: - 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) Exclusion Criteria: - Diagnosis of heart disease requiring use of nitrates - Inability to be examined monthly or bi-monthly

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Donald Jackson Coleman, MD Principal Investigator Columbia University
Overall Contact

Last Name: Suzanne Daly, RN, BSN

Email: [email protected]

Location
Facility: Status: Contact: Columbia University Medical Center, Edward Harkness Eye Institute Suzanne Daly, RN,BSN [email protected]
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Columbia University

Investigator Full Name: Donald Coleman

Investigator Title: Professor of Ophthalmology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard of Care Sildenafil

Type: Active Comparator

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

Label: Sildenafil

Type: Active Comparator

Description: Participants are prescribed sildenafil 40-80 mg daily.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Participants are assigned to the investigational sildenafil arm with a dose of 40-80mg daily, or the records review arm when taking sildenafil off-label.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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