Actively Recruiting
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
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.
CONDITIONS
Official 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 or older
- Patients undergoing pars plana vitrectomy and/or scleral buckle for recurrent rhegmatogenous retinal detachment due to proliferative vitreoretinopathy
- Patients with rhegmatogenous retinal detachment and proliferative vitreoretinopathy grade C or D
- Patients who have had at least one prior vitreoretinal surgery for retinal detachment in the same eye with clinical evidence of retinal re-detachment
- Patients willing and able to participate voluntarily
- Patients undergoing combined phacoemulsification with vitrectomy and/or scleral buckle are also eligible
- Any surgical technique, including relaxing retinotomy or retinectomy during vitrectomy, is allowed
You will not qualify if you...
- History of tractional or exudative retinal detachment
- Severe non-proliferative or proliferative diabetic retinopathy
- Planned ocular surgery following pars plana vitrectomy
- Primary rhegmatogenous retinal detachment
- Female patients under 50 years of age (childbearing potential)
- Pre-existing bone marrow suppression or cytopenias
- Pre-existing interstitial lung disease
- Use of other medications or treatments, including rescue therapy, is allowed before or during the trial
AI-Screening
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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
CONTACT
M
Marko Popovic, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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