NCT05523869

Brief Summary

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2023

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

August 29, 2022

Last Update Submit

February 7, 2025

Conditions

Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Recurrent RRD secondary to PVR

    6 months or last follow-up

Secondary Outcomes (5)

  • Best corrected visual acuity

    6 months or last follow-up

  • Proliferative vitreoretinopathy grade

    6 months or last follow-up

  • Retinal reattachment rate

    6 months or last follow-up

  • Complications

    6 months or last follow-up

  • Best corrected visual acuity change from baseline

    6 months or last follow-up

Study Arms (2)

Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle

EXPERIMENTAL
Drug: Intravitreal topotecanProcedure: Pars plana vitrectomy with or without scleral buckle

Pars plana vitrectomy with or without scleral buckle

ACTIVE COMPARATOR
Procedure: Pars plana vitrectomy with or without scleral buckle

Interventions

Intravitreal topotecanDRUG

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.

Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Pars plana vitrectomy with or without scleral bucklePROCEDURE

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

Intravitreal topotecan with pars plana vitrectomy with or without scleral bucklePars plana vitrectomy with or without scleral buckle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Interventions

Scleral Buckling

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Rajeev Muni, MD

CONTACT

416-867-7411rajeev.muni@utoronto.ca

Marko Popovic, MD

CONTACT

416-867-7411marko.popovic@mail.utoronto.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 31, 2022

Study Start

February 23, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)