Isotretinoin for Proliferative Vitreoretinopathy

Phase 4

Completed

• Conditions: Proliferative Vitreoretinopathy
• Interventions: Drug: Isotretinoin

• Registration Number: NCT01445028
• Lead Sponsor: Wills Eye

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 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-03
• Primary Completion: 2013-08
• Study Completion: 2015-08
• Results First Submitted: 2017-03-31
• Results First Submitted QC: 2017-03-31
• Results First Posted: 2017-05-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary, high-risk retinal detachment	Isotretinoin	Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Recurrent RD associated with PVR	Isotretinoin	Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Primary Outcome Measures

Name	Time	Method
Rate of Retinal Attachment	3 months	We will evaluate all patients for retinal attachment at 3 months.

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States