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The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Dec 1, 2026 to Dec 1, 2027
    • Start date: Apr 1, 2026 to Sep 1, 2026
    • Study completion date: Mar 1, 2027 to Sep 1, 2028
    v4
  2. Notable Primary completion date: Mar 1, 2026 to Dec 1, 2026
    • Start date: Jan 1, 2025 to Apr 1, 2026
    • Study completion date: Mar 1, 2026 to Mar 1, 2027
    v3
  3. Notable Start date: Jul 1, 2024 to Jan 1, 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy (PVR) or resulting from an open globe injury, and compare the outcomes to those who do no receive intravitreal topotecan. The main objectives it aims to achieve are: * to study the safety profile of intravitreal topotecan in the treatment of PVR * to evaluate the efficacy of intravitreal topotecan in treating PVR. Post-consent, participants will: * undergo vitrectomy (with or without scleral buckle) as part of standard treatment for retinal detachment. * receive intravitreal topotecan at the time of surgery, post-operative day 7 and post-operative day 28 (if randomized to receive the medication) * come in at post-operative day 1, 7, 28, 56, 84, 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula, have their intraocular pressure and visual acuity measured and their adverse events monitored, if any. Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment, rate of retinal reattachment and PVR grade 6 months after surgery.
Trial Details
NCT Number NCT06425419
Lead Sponsor Massachusetts Eye and Ear Infirmary
Conditions
(from sponsor)
Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy, Rhegmatogenous Retinal Detachment
Related terms Vitreoretinopathy, Proliferative
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov