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Isotretinoin for Proliferative Vitreoretinopathy

Information source: Wills Eye
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Proliferative Vitreoretinopathy

Intervention: Isotretinoin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Wills Eye

Official(s) and/or principal investigator(s):
Richard S Kaiser, MD, Principal Investigator, Affiliation: Wills Eye Institute

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Rate of retinal attachment

Secondary outcome: Epiretinal membrane formation

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Wills Eye Institute, Philadelphia, Pennsylvania 19107, United States
Additional Information

Starting date: September 2011
Last updated: June 18, 2013

Page last updated: August 23, 2015

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