This trial is active, not recruiting.

Condition proliferative vitreoretinopathy
Treatment isotretinoin
Phase phase 4
Sponsor Wills Eye
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Isotretinoin 20mg daily for 12 weeks
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin 20mg daily for 12 weeks

Primary Outcomes

Rate of retinal attachment
time frame: 6 months

Secondary Outcomes

Epiretinal membrane formation
time frame: 6 months

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Wills Eye.