Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intravitreal topotecan
- Retinal detachment surgery
Treatment groups
394 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov