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

Phase 2

Recruiting

• Conditions: Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
• Interventions: Drug: Intravitreal topotecan; Procedure: Pars plana vitrectomy with or without scleral buckle

• Registration Number: NCT05523869
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2023-02-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle	Pars plana vitrectomy with or without scleral buckle	-
Pars plana vitrectomy with or without scleral buckle	Pars plana vitrectomy with or without scleral buckle	-
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle	Intravitreal topotecan	-

Primary Outcome Measures

Name	Time	Method
Recurrent RRD secondary to PVR	6 months or last follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada