Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment (TOPO-PT)

March 3, 2025 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

394

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
        • Contact:
        • Contact:
          • Rajeev H Muni, MD MSc FRCSC
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Contact:
          • Peter J Kertes, MD CM FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18 years and older
  2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
  3. 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:

  1. Patients with a history of exudative retinal detachment
  2. Patients with severe non-proliferative or proliferative diabetic retinopathy
  3. Patients with other planned ocular surgery following pars plana vitrectomy
  4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
  5. Patients with pre-existing bone marrow suppression or cytopenias
  6. Patients with pre-existing interstitial lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal topotecan with retinal detachment surgery
Intravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively.
Drug: Intravitreal topotecan
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
Procedure: Retinal detachment surgery
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Other Names:
  • Pars plana vitrectomy
  • Pneumatic retinopexy
  • Scleral buckling
Active Comparator: Retinal detachment surgery
Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan.
Procedure: Retinal detachment surgery
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Other Names:
  • Pars plana vitrectomy
  • Pneumatic retinopexy
  • Scleral buckling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Time Frame: 6 months or last follow-up
6 months or last follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade of proliferative vitreoretinopathy
Time Frame: 6 months or last follow-up
6 months or last follow-up
Rate of primary retinal reattachment
Time Frame: 6 months or last follow-up
6 months or last follow-up
Rate of final retinal reattachment
Time Frame: 6 months or last follow-up
6 months or last follow-up
Best-corrected visual acuity
Time Frame: 6 months or last follow-up
6 months or last follow-up
Change in best-corrected visual acuity from baseline
Time Frame: 6 months or last follow-up
6 months or last follow-up
Rate of complications
Time Frame: 6 months or last follow-up
6 months or last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPO-PT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe