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Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

This study is currently recruiting participants.
Verified September 2011 by Wills Eye
Sponsor:
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye
ClinicalTrials.gov Identifier:
NCT01445028
First received: September 29, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Rate of retinal attachment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will evaluate all patients for retinal attachment at 3 and 6-months following enrollment in the study.


Secondary Outcome Measures:
  • Epiretinal membrane formation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary, high-risk retinal detachment Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks
Experimental: Recurrent retinal detachment associated with PVR 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 formation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445028

Contacts
Contact: Nikolas J London, MD 215-928-3300 nik.london@gmail.com

Locations
United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nikolas J London, MD     215-928-3300     nik.london@gmail.com    
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Richard S Kaiser, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: Richard S. Kaiser, Associate Clinical Professor, Wills Eye
ClinicalTrials.gov Identifier: NCT01445028     History of Changes
Other Study ID Numbers: WEI-DELIVER
Study First Received: September 29, 2011
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Isotretinoin
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013