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Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

Study acronym: TOPO-RD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 11, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Feb 2025 to Feb 2026v5
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary and study completion dates: Oct 2024 to Feb 2025 · Start date changed from estimate of Nov 2022 to Feb 23, 2023 · 1 morev4 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary and study completion dates: Oct 2024 to Feb 2025
    • Start date changed from estimate of Nov 2022 to Feb 23, 2023
    • Eligibility criteria expanded, about 138 words

    See this version in full on ClinicalTrials.gov ↗

  3. Phase: Phase 1/2 to Phase 2 Interventions: Intravitreal topotecan (Drug), Pars plana vitrectomy and/or scleral buckle (Procedure) to Intravitreal topotecan (Drug), Pars plana vitrectomy with or without scleral buckle (Procedure) · Secondary endpoints: details revised at 5 of 5 entriesv3 Show 2 more changesShow less
    • Interventions: Intravitreal topotecan (Drug), Pars plana vitrectomy and/or scleral buckle (Procedure) to Intravitreal topotecan (Drug), Pars plana vitrectomy with or without scleral buckle (Procedure)
    • Secondary endpoints: details revised at 5 of 5 entries
  4. Primary endpoint revised Interventions: Intravitreal topotecan (Drug), Pars plana vitrectomy (Procedure) to Intravitreal topotecan (Drug), Pars plana vitrectomy and/or scleral buckle (Procedure) · Secondary endpoints: 4 to 5 · Eligibility criteria expanded, about 2 wordsv2 Show 3 more changesShow less
    • Interventions: Intravitreal topotecan (Drug), Pars plana vitrectomy (Procedure) to Intravitreal topotecan (Drug), Pars plana vitrectomy and/or scleral buckle (Procedure)
    • Secondary endpoints: 4 to 5
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT05523869
Lead Sponsor Unity Health Toronto
Conditions Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov