Phase 4 N=112 Prevention

Isotretinoin for Proliferative Vitreoretinopathy

Proliferative Vitreoretinopathy

Bottom Line

View on ClinicalTrials.gov: NCT01445028 ↗

Enrolled (actual)

112

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Rate of Retinal Attachment — 50; 42 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Isotretinoin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wills Eye
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Retinal Attachment	50; 42	—

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.

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.

View full record on ClinicalTrials.gov →

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.