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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01445028
Other study ID # WEI-DELIVER
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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