- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01445028
Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)
April 30, 2018 updated by: Richard S. Kaiser, Wills Eye
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
109
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primary, high-risk retinal detachment
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
|
Isotretinoin 20mg daily for 12 weeks
|
Experimental: Recurrent RD associated with PVR
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
|
Isotretinoin 20mg daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Retinal Attachment
Time Frame: 3 months
|
We will evaluate all patients for retinal attachment at 3 months.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard S Kaiser, MD, Wills Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 29, 2011
First Submitted That Met QC Criteria
September 29, 2011
First Posted (Estimate)
October 3, 2011
Study Record Updates
Last Update Posted (Actual)
June 1, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEI-DELIVER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proliferative Vitreoretinopathy
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Shahid Beheshti University of Medical SciencesUnknownProliferative VitreoretinopathyIran, Islamic Republic of
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Shahid Beheshti University of Medical SciencesCompletedProliferative VitreoretinopathyIran, Islamic Republic of
-
Stanford UniversityWithdrawnProliferative VitreoretinopathyUnited States
-
Centro Oftalmológico Dr CharlesCompletedProliferative VitreoretinopathyArgentina
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National Eye Institute (NEI)CompletedRetinal Detachment | Proliferative Vitreoretinopathy
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Shahid Beheshti University of Medical SciencesUnknownProliferative VitreoretinopathyIran, Islamic Republic of
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Shanghai 10th People's HospitalUnknown
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University of Health Sciences LahoreRecruitingProliferative VitreoretinopathyPakistan
-
Unity Health TorontoRecruitingProliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentCanada
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