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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

Tracking Information
First Submitted Date  ICMJE September 29, 2011
First Posted Date  ICMJE October 3, 2011
Results First Submitted Date  ICMJE March 31, 2017
Results First Posted Date  ICMJE May 11, 2017
Last Update Posted Date June 1, 2018
Study Start Date  ICMJE September 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
Rate of Retinal Attachment [ Time Frame: 3 months ]
We will evaluate all patients for retinal attachment at 3 months.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2011)
Rate of Retinal Attachment [ Time Frame: 6 months ]
We will evaluate all patients for retinal attachment at 3 and 6-months following enrollment in the study.
Change History Complete list of historical versions of study NCT01445028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2011)
Epiretinal membrane formation [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isotretinoin for Proliferative Vitreoretinopathy
Official Title  ICMJE Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Proliferative Vitreoretinopathy
Intervention  ICMJE Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Primary, high-risk retinal detachment
    Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
    Intervention: Drug: Isotretinoin
  • Experimental: Recurrent RD associated with PVR
    Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
    Intervention: Drug: Isotretinoin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2017)
109
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2011)
70
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01445028
Other Study ID Numbers  ICMJE WEI-DELIVER
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard S. Kaiser, Wills Eye
Study Sponsor  ICMJE Wills Eye
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard S Kaiser, MD Wills Eye Institute
PRS Account Wills Eye
Verification Date April 2018

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