Sildenafil for Treatment of Choroidal Ischemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-11

Study Completion Date

2020-02-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care Sildenafil

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

Group Type ACTIVE_COMPARATOR

Standard of Care Sildenafil

Intervention Type OTHER

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

Sildenafil

Participants are prescribed sildenafil 40-80 mg daily.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

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.

Ocular Coherence Tomography-Angiography (OCT-A)

Intervention Type DIAGNOSTIC_TEST

Retinal photographs will be taken at each study visit.

Visual Acuity (VA)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Standard of Care Sildenafil

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

Intervention Type OTHER

Ocular Coherence Tomography-Angiography (OCT-A)

Retinal photographs will be taken at each study visit.

Intervention Type DIAGNOSTIC_TEST

Visual Acuity (VA)

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

Intervention Type OTHER

Other Intervention Names

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Eligibility Criteria

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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)