Actively Recruiting
A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Led by Unity Health Toronto · Updated on 2025-02-11
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravitreal topotecan, a drug with anti-inflammatory, anti-proliferative, and anti-fibrotic properties, for treating proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). This phase II trial aims to investigate the safety and effectiveness of intravitreal topotecan, which has shown promising results in cell cultures and has been used in treating retinoblastoma without reported adverse events at certain doses. Participants will receive pars plana vitrectomy (PPV) with or without scleral buckle surgery, combined with intravitreal topotecan injections. The topotecan dose is 8 micrograms in 0.1 mL, administered seven times: once preoperatively within one week before surgery, once during surgery, and then postoperatively at 2, 4, 8, 12, and 16 weeks. A comparison group will undergo the standard PPV with or without scleral buckle without the drug. Throughout the study, participants will be monitored for recurrence of RRD due to PVR, visual acuity, PVR grade, retinal reattachment rate, and any complications at 6 months or the last follow-up. Researchers will assess changes in best corrected visual acuity from baseline. The study involves ongoing safety and efficacy evaluations to understand the impact of intravitreal topotecan on severe PVR in RRD patients.
CONDITIONS
Brief Title
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older
- Patients undergoing pars plana vitrectomy and/or scleral buckle for recurrent rhegmatogenous retinal detachment due to proliferative vitreoretinopathy
- Patients with proliferative vitreoretinopathy grade C or D
- Patients who have previously had at least one vitreoretinal surgery for retinal detachment in the same eye and experienced retinal re-detachment
- Patients who are voluntarily able and willing to participate
- Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckle are included
- Any surgical technique, including relaxing retinotomy or retinectomy during vitrectomy, will be considered
You will not qualify if you...
- Patients with a history of tractional or exudative retinal detachment
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with other planned ocular surgery following pars plana vitrectomy
- Patients with primary rhegmatogenous retinal detachment
- Female patients of childbearing age (less than 50 years old)
- Patients with pre-existing bone marrow suppression or cytopenias
- Patients with pre-existing interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive intravitreal topotecan injections administered preoperatively, intraoperatively during pars plana vitrectomy with or without scleral buckle surgery, and postoperatively at regular intervals.
7 injections including preoperative, intraoperative, and postoperative visits at 2, 4, 8, 12, and 16 weeks
Duration - Up to 6 months or last follow-up
Participants are monitored for outcomes including retinal reattachment, visual acuity, and complications after treatment completion.
Visits for outcome assessments up to 6 months
Trial Site Locations
Total: 2 locations
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4Y 1H1
Actively Recruiting
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
R
Rajeev Muni, MD
M
Marko Popovic, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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