A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Overview
- Phase
- Phase 2
- Intervention
- Intravitreal topotecan
- Conditions
- Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
- Sponsor
- Unity Health Toronto
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Recurrent RRD secondary to PVR
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Intervention: Intravitreal topotecan
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Intervention: Pars plana vitrectomy with or without scleral buckle
Pars plana vitrectomy with or without scleral buckle
Intervention: Pars plana vitrectomy with or without scleral buckle
Outcomes
Primary Outcomes
Recurrent RRD secondary to PVR
Time Frame: 6 months or last follow-up
Secondary Outcomes
- Proliferative vitreoretinopathy grade(6 months or last follow-up)
- Best corrected visual acuity change from baseline(6 months or last follow-up)
- Best corrected visual acuity(6 months or last follow-up)
- Retinal reattachment rate(6 months or last follow-up)
- Complications(6 months or last follow-up)