Isotretinoin for Proliferative Vitreoretinopathy

NCT ID: NCT01445028

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-08-31

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.

Conditions

Proliferative Vitreoretinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Primary, high-risk retinal detachment

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Group Type: EXPERIMENTAL

Isotretinoin

Intervention Type: DRUG

Isotretinoin 20mg daily for 12 weeks

Recurrent RD associated with PVR

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Group Type: EXPERIMENTAL

Isotretinoin

Intervention Type: DRUG

Isotretinoin 20mg daily for 12 weeks

Interventions

Isotretinoin

Isotretinoin 20mg daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

Richard S. Kaiser

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard S Kaiser, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Institute

Locations

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

WEI-DELIVER

Identifier Type: -

Identifier Source: org_study_id