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Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

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ClinicalTrials.gov Identifier: NCT01445028
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : May 11, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Proliferative Vitreoretinopathy Drug: Isotretinoin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
Study Start Date : September 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary, high-risk retinal detachment
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks

Experimental: Recurrent RD associated with PVR
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks




Primary Outcome Measures :
  1. Rate of Retinal Attachment [ Time Frame: 3 months ]
    We will evaluate all patients for retinal attachment at 3 months.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445028


Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Richard S Kaiser, MD Wills Eye Institute

Responsible Party: Richard S. Kaiser, Associate Clinical Professor, Wills Eye
ClinicalTrials.gov Identifier: NCT01445028     History of Changes
Other Study ID Numbers: WEI-DELIVER
First Posted: October 3, 2011    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: June 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Isotretinoin
Dermatologic Agents