Phase 4
Completed N=112
Isotretinoin for Proliferative Vitreoretinopathy
Source: ClinicalTrials.gov NCT01445028 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Rate of Retinal Attachment — 50; 42 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Retinal Attachment |
50; 42 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01445028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.