Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Unity Health Toronto
- Enrollment
- 394
- Locations
- 2
- Primary Endpoint
- Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years and older
- •Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
- •Patients who are voluntarily able and willing to participate
- •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
- •Patients with a history of exudative retinal detachment
- •Patients with severe non-proliferative or proliferative diabetic retinopathy
- •Patients with other planned ocular surgery following pars plana vitrectomy
- •Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
- •Patients with pre-existing bone marrow suppression or cytopenias
- •Patients with pre-existing interstitial lung disease
Arms & Interventions
Intravitreal topotecan with retinal detachment surgery
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.
Intervention: Intravitreal topotecan (Drug)
Intravitreal topotecan with retinal detachment surgery
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.
Intervention: Retinal detachment surgery (Procedure)
Retinal detachment surgery
Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan.
Intervention: Retinal detachment surgery (Procedure)
Outcomes
Primary Outcomes
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Time Frame: 6 months or last follow-up
Secondary Outcomes
- 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(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)