A Phase 2 interventional study of Intravitreal topotecan and Retinal detachment surgery in Retinal Detachment Rhegmatogenous and Proliferative Vitreoretinopathy, sponsored by Unity Health Toronto. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Unity Health Toronto · Phase 2, Interventional, and Prevention
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.
43 studies on the registry are indexed under Vitreoretinopathy, Proliferative; 11 are open to participants now.
This study's planned enrollment of 394 is above the median of 64 across 30 interventional studies indexed under Vitreoretinopathy, Proliferative.
Browse Vitreoretinopathy, Proliferative studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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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:
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.
Drug: Intravitreal topotecan · Procedure: Retinal detachment surgery
Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan.
Procedure: Retinal detachment surgery
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.
Also known as: Topotecan
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Also known as: Pars plana vitrectomy, Pneumatic retinopexy, Scleral buckling
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Time frame: 6 months or last follow-up
Grade of proliferative vitreoretinopathy
Time frame: 6 months or last follow-up
Rate of primary retinal reattachment
Time frame: 6 months or last follow-up
Rate of final retinal reattachment
Time frame: 6 months or last follow-up
Best-corrected visual acuity
Time frame: 6 months or last follow-up
Change in best-corrected visual acuity from baseline
Time frame: 6 months or last follow-up
Rate of complications
Time frame: 6 months or last follow-up
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Apr 2027, 25 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topotecan
Vitreoretinopathy, Proliferative →