Status:
COMPLETED
Isotretinoin for Proliferative Vitreoretinopathy
Lead Sponsor:
Wills Eye
Conditions:
Proliferative Vitreoretinopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. The purpose of this study is to evaluate the effect of oral isotr...
Detailed Description
Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR. This is a prospective stud...
Eligibility Criteria
Inclusion
- 18-70 year-old men or 50-70 year-old, post-menopausal women.
- Healthy enough to participate in the study.
- Willing and able to consent to participation.
- Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or
- Primary RD (retinal detachment) associated with one or more high-risk features
Exclusion
- History of hypersensitivity to isotretinoin.
- Current use of a corticosteroid (excluding topical).
- Any history of depression, anorexia, liver or pancreatic disease.
- More than one prior surgical RD repair.
- Patients with closed funnel retinal detachments.
- Patients with chronic retinal detachment, defined as longer than 12 weeks.
- Any use an oral retinoid within 6 months.
- Systemic chemotherapy within 6 months.
- Patients taking supplemental vitamin A.
- Corneal opacity sufficient to impair surgical view.
- Proliferative diabetic retinopathy.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01445028
Start Date
September 1 2011
End Date
August 1 2015
Last Update
June 1 2018
Active Locations (1)
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1
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107