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NCT Number: NCT05523869

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be enrolled, patients need to meet the following inclusion criteria:

  • patients aged 18 years and older
  • patients who undergo PPV and/or SB for recurrent RRD due to PVR
  • patients with RRD and PVR grade C or D
  • patients who have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to have previously received at least one vitreoretinal surgery for RRD, including pneumatic retinopexy, pars plana vitrectomy and/or scleral buckle, and to have clinical documentation supporting re-detachment of the retina after one or more vitreoretinal surgeries for RRD in the same eye. This cohort of patients is expected to have an extremely guarded visual prognosis and visual potential.
  • patients who are voluntarily able and willing to participate Patients undergoing combined phacoemulsification and PPV and/or SB will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during PPV.

The following subject exclusion criteria will be considered:

  • 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 PPV
  • patients with primary RRD
  • female patients of childbearing age (i.e. less than 50 years old).
  • patients with pre-existing bone marrow suppression or cytopenias
  • patients with pre-existing interstitial lung disease (ILD) Any other medications or treatments, including rescue therapy, will be permitted before and/or during the trial.

Treatment and study plan

Intravitreal topotecan

Drug

Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.

Pars plana vitrectomy with or without scleral buckle

Procedure

Standard three-port pars plana vitrectomy with or without scleral buckle.

Primary outcomes

  1. Recurrent RRD secondary to PVR

    Time frame: 6 months or last follow-up

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 6 months or last follow-up

  2. Proliferative vitreoretinopathy grade

    Time frame: 6 months or last follow-up

  3. Retinal reattachment rate

    Time frame: 6 months or last follow-up

  4. Complications

    Time frame: 6 months or last follow-up

  5. Best corrected visual acuity change from baseline

    Time frame: 6 months or last follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Marko Popovic, MD

CONTACT

[email protected]

416-867-7411

Rajeev Muni, MD

CONTACT

[email protected]

416-867-7411

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

Acronym: TOPO-RD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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