Isotretinoin for Proliferative Vitreoretinopathy
DELIVER
Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
1 other identifier
interventional
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
May 11, 2017
CompletedJune 1, 2018
April 1, 2018
1.9 years
September 29, 2011
March 31, 2017
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Retinal Attachment
We will evaluate all patients for retinal attachment at 3 months.
3 months
Study Arms (2)
Primary, high-risk retinal detachment
EXPERIMENTALOral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Recurrent RD associated with PVR
EXPERIMENTALOral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Interventions
Isotretinoin 20mg daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wills Eyelead
Study Sites (1)
Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Kaiser, MD
- Organization
- MidAtlantic Retina
Study Officials
- PRINCIPAL INVESTIGATOR
Richard S Kaiser, MD
Wills Eye Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Clinical Professor
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 3, 2011
Study Start
September 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2015
Last Updated
June 1, 2018
Results First Posted
May 11, 2017
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share