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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGSt. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGRecurrent 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
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