Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

Wills Eye

Status and phase: Completed; Phase 4

Conditions: Proliferative Vitreoretinopathy

Treatments: Drug: Isotretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT01445028

WEI-DELIVER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Primary, high-risk retinal detachment

Experimental group

Description:

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Treatment:

Drug: Isotretinoin

Recurrent RD associated with PVR

Experimental group

Description:

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Treatment:

Drug: Isotretinoin