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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle | Experimental |
| |
| Pars plana vitrectomy with or without scleral buckle | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal topotecan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent RRD secondary to PVR | 6 months or last follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | 6 months or last follow-up | |
| Proliferative vitreoretinopathy grade | 6 months or last follow-up | |
| Retinal reattachment rate |
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To be enrolled, patients need to meet the following inclusion criteria:
The following subject exclusion criteria will be considered:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajeev Muni, MD | Contact | 416-867-7411 | rajeev.muni@utoronto.ca | |
| Marko Popovic, MD | Contact | 416-867-7411 | marko.popovic@mail.utoronto.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4Y 1H1 | Canada |
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|
| Pars plana vitrectomy with or without scleral buckle | Procedure | Standard three-port pars plana vitrectomy with or without scleral buckle. |
|
| 6 months or last follow-up |
| Complications | 6 months or last follow-up |
| Best corrected visual acuity change from baseline | 6 months or last follow-up |
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| ID | Term |
|---|---|
| D012591 | Scleral Buckling |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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