drugset / Trial / NCT05523869

Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

NCT05523869

Phase 2 Recruiting 50 enrolled Unity Health Toronto
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-23
Primary completion
2026-02
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Topotecan Small molecule 8 ug Intravitreal