Intravitreal topotecan with pars plana vitrectomy for Proliferative Vitreoretinopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. Michael's Hospital, Toronto, CanadaProliferative VitreoretinopathyPars plana vitrectomy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will investigate if intravitreal topotecan is safe and effective at treating severe PVR in people with RRD. It's been used to treat retinoblastoma with no adverse events at doses of 5-30 micrograms per injection.

Eligible Conditions
  • Proliferative Vitreoretinopathy

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6 months or last follow-up

Month 6
Best corrected visual acuity
Best corrected visual acuity change from baseline
Complications
Proliferative vitreoretinopathy
Recurrent RRD secondary to PVR
Retinal reattachment rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

Pars plana vitrectomy
1 of 6
Pars plana vitrectomy with or without scleral buckle
1 of 6
Pars plana vitrectomy and/or scleral buckle
1 of 6
Intravitreal topotecan with pars plana vitrectomy
1 of 6
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
1 of 6
Intravitreal topotecan with pars plana vitrectomy and/or scleral buckle
1 of 6

Active Control

Experimental Treatment

50 Total Participants · 6 Treatment Groups

Primary Treatment: Intravitreal topotecan with pars plana vitrectomy · No Placebo Group · Phase 2

Intravitreal topotecan with pars plana vitrectomyExperimental Group · 2 Interventions: Pars plana vitrectomy, Intravitreal topotecan · Intervention Types: Procedure, Drug
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckleExperimental Group · 2 Interventions: Intravitreal topotecan, Pars plana vitrectomy with or without scleral buckle · Intervention Types: Drug, Procedure
Intravitreal topotecan with pars plana vitrectomy and/or scleral buckleExperimental Group · 2 Interventions: Intravitreal topotecan, Pars plana vitrectomy and/or scleral buckle · Intervention Types: Drug, Procedure
Pars plana vitrectomy
Procedure
ActiveComparator Group · 1 Intervention: Pars plana vitrectomy · Intervention Types: Procedure
Pars plana vitrectomy with or without scleral buckle
Procedure
ActiveComparator Group · 1 Intervention: Pars plana vitrectomy with or without scleral buckle · Intervention Types: Procedure
Pars plana vitrectomy and/or scleral buckle
Procedure
ActiveComparator Group · 1 Intervention: Pars plana vitrectomy and/or scleral buckle · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pars plana vitrectomy
2017
N/A
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months or last follow-up

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
500 Previous Clinical Trials
376,405 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You want to be part of the study and are able to give your consent.
You are having eye surgery that involves removing the cloudiness of your lens and repairing your retina at the same time, using different surgical techniques.

Frequently Asked Questions

What is the maximum number of participants permitted in this experiment?

"Affirmative. Based on the information furnished by clinicaltrials.gov, this medical trial is actively searching for volunteers to participate in its research. This study was posted on February 23rd 2023 and last updated four days later; it requires 50 individuals from two different sites." - Anonymous Online Contributor

Unverified Answer

Are enrollment opportunities currently available for the trial?

"According to the information present on clinicaltrials.gov, this trial is actively seeking participants. First posted on February 23rd 2023, it has recently been updated as of February 27th 2023." - Anonymous Online Contributor

Unverified Answer

Has the combination of Intravitreal topotecan and pars plana vitrectomy been given a clearance by the Food and Drug Administration?

"Given the lack of data regarding efficacy, Intravitreal topotecan with pars plana vitrectomy was assigned a safety score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.