Isotretinoin for Proliferative Vitreoretinopathy

Proliferative Vitreoretinopathy Clinical Trial

— DELIVER  

Official title:

Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445028
• Other study ID #: WEI-DELIVER
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Proliferative Vitreoretinopathy

Intervention

Drug:
• Isotretinoin
Isotretinoin 20mg daily for 12 weeks

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Retinal Attachment	We will evaluate all patients for retinal attachment at 3 months.	3 months