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NCT Number: NCT06818721

Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment

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.

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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

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About this study

Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.

Exclusion criteria

  • 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
  • Patients with pre-existing bone marrow suppression or cytopenias
  • Patients with pre-existing interstitial lung disease

Treatment and study plan

Intravitreal topotecan

Drug

Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections.

Other names: Topotecan

Retinal detachment surgery

Procedure

Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).

Other names: Pars plana vitrectomy, Pneumatic retinopexy, Scleral buckling

Primary outcomes

  1. Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy

    Time frame: 6 months or last follow-up

Secondary outcomes

  1. Grade of proliferative vitreoretinopathy

    Time frame: 6 months or last follow-up

  2. Rate of primary retinal reattachment

    Time frame: 6 months or last follow-up

  3. Rate of final retinal reattachment

    Time frame: 6 months or last follow-up

  4. Best-corrected visual acuity

    Time frame: 6 months or last follow-up

  5. Change in best-corrected visual acuity from baseline

    Time frame: 6 months or last follow-up

  6. Rate of complications

    Time frame: 6 months or last follow-up

Study contacts

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

Marko M Popovic, MD MPH FRCSC

CONTACT

[email protected]

416-867-7411

Rajeev H Muni, MD MSc FRCSC

CONTACT

[email protected]

416-867-7411

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study

Acronym: TOPO-PT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Mar 6, 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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