Isotretinoin for Proliferative Vitreoretinopathy
This trial is active, not recruiting.
|Start date||September 2011|
|End date||August 2013|
|Trial size||70 participants|
|Trial identifier||NCT01445028, WEI-DELIVER|
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 isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Rate of retinal attachment
time frame: 6 months
Epiretinal membrane formation
time frame: 6 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - 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 Criteria: - 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.
|Official title||Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy|
|Principal investigator||Richard S Kaiser, MD|
|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 study to evaluate a low dose of oral isotretinoin in this regard. There are two arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes with primary detachment and features associated with a high risk of PVR formation. Eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.|
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