A Phase 2 interventional study of Intravitreal topotecan and Pars plana vitrectomy with or without scleral buckle in Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, sponsored by Unity Health Toronto. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Unity Health Toronto · Phase 2, Interventional, and Treatment
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 132 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be enrolled, patients need to meet the following inclusion criteria:
The following subject exclusion criteria will be considered:
Drug: Intravitreal topotecan · Procedure: Pars plana vitrectomy with or without scleral buckle
Procedure: Pars plana vitrectomy with or without scleral buckle
Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.
Standard three-port pars plana vitrectomy with or without scleral buckle.
Recurrent RRD secondary to PVR
Time frame: 6 months or last follow-up
Best corrected visual acuity
Time frame: 6 months or last follow-up
Proliferative vitreoretinopathy grade
Time frame: 6 months or last follow-up
Retinal reattachment rate
Time frame: 6 months or last follow-up
Complications
Time frame: 6 months or last follow-up
Best corrected visual acuity change from baseline
Time frame: 6 months or last follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2026, 36 months after the start.
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Studies of the drug tested here: Topotecan