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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

September 29, 2011
June 18, 2013
September 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01445028 on ClinicalTrials.gov Archive Site
Epiretinal membrane formation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Isotretinoin for Proliferative Vitreoretinopathy
Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Proliferative Vitreoretinopathy
Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks
  • Experimental: Primary, high-risk retinal detachment
    Intervention: Drug: Isotretinoin
  • Experimental: Recurrent RD associated with PVR
    Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
    Intervention: Drug: Isotretinoin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01445028
WEI-DELIVER
No
Richard S. Kaiser, Wills Eye
Wills Eye
Not Provided
Principal Investigator: Richard S Kaiser, MD Wills Eye Institute
Wills Eye
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP