NCT01445028

Isotretinoin for Proliferative Vitreoretinopathy

Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.

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 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.

Conditions

• Proliferative Vitreoretinopathy

Interventions

Type	Name	Description
DRUG	Isotretinoin	Isotretinoin 20mg daily for 12 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2015-08-01
• First posted: 2011-10-03
• Last updated: 2018-06-01
• Results posted: 2017-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study