Isotretinoin for Proliferative Vitreoretinopathy

Study Overview
=================
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.

Official Title
-----------------
Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

Conditions
-----------------
Proliferative Vitreoretinopathy

Intervention / Treatment
-----------------
* Drug: Isotretinoin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary, high-risk retinal detachment<br>Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy | Drug: Isotretinoin<br>* Isotretinoin 20mg daily for 12 weeks<br>|
| Experimental: Recurrent RD associated with PVR<br>Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy | Drug: Isotretinoin<br>* Isotretinoin 20mg daily for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Retinal Attachment | We will evaluate all patients for retinal attachment at 3 months. | 3 months |