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

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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 I/II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unity Health Toronto
• Treatments: Topotecan

Criteria

Inclusion criteria:

1. Patients aged 18 years and older of any gender or race

2. Patients who undergo pars plana vitrectomy for rhegmatogenous retinal detachment or in the context of open globe injury

3. Patients with proliferative vitreoretinopathy grade C or D at initial presentation.

4. Patients must be willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits

Exclusion criteria:

1. History of tractional or exudative retinal detachment

2. History of severe non-proliferative or proliferative diabetic retinopathy

3. Patients with other planned ocular surgery following PPV

4. Females of childbearing age