Clinical trial NCT06818721: Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment
Official title: Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Retinal Detachment Rhegmatogenous
Proliferative Vitreoretinopathy
Keywords: topotecan
proliferative vitreoretinopathy
rhegmatogenous retinal detachment
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
3. 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:

1. Patients with a history of exudative retinal detachment
2. Patients with severe non-proliferative or proliferative diabetic retinopathy
3. Patients with other planned ocular surgery following pars plana vitrectomy
4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
5. Patients with pre-existing bone marrow suppression or cytopenias
6. Patients with pre-existing interstitial lung disease

Primary outcomes:
measure: Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
timeFrame: 6 months or last follow-up
Secondary outcomes:
measure: Grade of proliferative vitreoretinopathy
timeFrame: 6 months or last follow-up
measure: Rate of primary retinal reattachment
timeFrame: 6 months or last follow-up
measure: Rate of final retinal reattachment
timeFrame: 6 months or last follow-up
measure: Best-corrected visual acuity
timeFrame: 6 months or last follow-up
measure: Change in best-corrected visual acuity from baseline
timeFrame: 6 months or last follow-up
measure: Rate of complications
timeFrame: 6 months or last follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: