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Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.
Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal topotecan with retinal detachment surgery | Experimental | Intravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively. |
|
| Retinal detachment surgery | Active Comparator | Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal topotecan | Drug | Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy | 6 months or last follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of proliferative vitreoretinopathy | 6 months or last follow-up | |
| Rate of primary retinal reattachment | 6 months or last follow-up | |
| Rate of final retinal reattachment |
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Inclusion Criteria:
Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajeev H Muni, MD MSc FRCSC | Contact | 416-867-7411 | rajeev.muni@utoronto.ca | |
| Marko M Popovic, MD MPH FRCSC | Contact | 416-867-7411 | marko.popovic@mail.utoronto.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | Canada |
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|
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| Retinal detachment surgery | Procedure | Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling). |
|
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| 6 months or last follow-up |
| Best-corrected visual acuity | 6 months or last follow-up |
| Change in best-corrected visual acuity from baseline | 6 months or last follow-up |
| Rate of complications | 6 months or last follow-up |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
|
| ID | Term |
|---|---|
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| D012591 | Scleral Buckling |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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