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Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445028
First Posted: October 3, 2011
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye
  Purpose
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 Intervention Phase
Proliferative Vitreoretinopathy Drug: Isotretinoin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Richard S. Kaiser, Wills Eye:

Primary Outcome Measures:
  • Rate of Retinal Attachment [ Time Frame: 3 months ]
    We will evaluate all patients for retinal attachment at 3 and 6-months following enrollment in the study.


Enrollment: 109
Study Start Date: September 2011
Study Completion Date: August 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: Richard S. Kaiser, Associate Clinical Professor, Wills Eye
ClinicalTrials.gov Identifier: NCT01445028     History of Changes
Other Study ID Numbers: WEI-DELIVER
First Submitted: September 29, 2011
First Posted: October 3, 2011
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017
Last Verified: March 2017
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