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Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye
ClinicalTrials.gov Identifier:
NCT01445028
First received: September 29, 2011
Last updated: June 18, 2013
Last verified: June 2013
  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:


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 Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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 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

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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: June 18, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014