Back to resultsIsotretinoin for Proliferative Vitreoretinopathy (DELIVER)
Primary Purpose
Proliferative Vitreoretinopathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
About this trial
This is an interventional prevention trial for Proliferative Vitreoretinopathy
Eligibility 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.
Sites / Locations
- Wills Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Primary, high-risk retinal detachment
Recurrent RD associated with PVR
Arm Description
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Outcomes
Primary Outcome Measures
Rate of Retinal Attachment
We will evaluate all patients for retinal attachment at 3 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01445028
Brief Title
Isotretinoin for Proliferative Vitreoretinopathy
Acronym
DELIVER
Official Title
Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary, high-risk retinal detachment
Arm Type
Experimental
Arm Description
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Arm Title
Recurrent RD associated with PVR
Arm Type
Experimental
Arm Description
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Intervention Description
Isotretinoin 20mg daily for 12 weeks
Primary Outcome Measure Information:
Title
Rate of Retinal Attachment
Description
We will evaluate all patients for retinal attachment at 3 months.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Kaiser, MD
Organizational Affiliation
Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Isotretinoin for Proliferative Vitreoretinopathy
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