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Anti-tumor antibiotic

Intravitreal Topotecan for Retinal Detachment (TOPO-RD Trial)

Phase 2
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months or last follow-up
Awards & highlights

TOPO-RD Trial 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.

Who is the study for?
This trial is for adults over 18 with a specific eye condition called rhegmatogenous retinal detachment (RRD) and severe proliferative vitreoretinopathy (PVR), who have had unsuccessful standard surgeries. It's not for those with certain diabetic eye issues, lung disease, other types of retinal detachment, or women under 50 likely to bear children.Check my eligibility
What is being tested?
The study tests intravitreal topotecan's effectiveness in treating PVR in RRD patients. Participants will receive this drug directly into the eye alongside standard surgical procedures like vitrectomy or scleral buckle to see if it improves outcomes.See study design
What are the potential side effects?
While no adverse events were reported at doses used for another eye condition, potential side effects may include local irritation, inflammation inside the eye, and possible impact on vision. The exact side effects related to RRD treatment are being studied.

TOPO-RD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months or last follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months or last follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrent RRD secondary to PVR
Secondary outcome measures
Best corrected visual acuity
Best corrected visual acuity change from baseline
Complications
+2 more

TOPO-RD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravitreal topotecan with pars plana vitrectomy with or without scleral buckleExperimental Treatment2 Interventions
Patients aged 18 years and older who undergo PPV with or without SB for RRD with PVR grade C or D will be recruited. To be enrolled, patients need to undergo PPV with or without SB for recurrent RRD due to PVR or open globe injury. Surgery can be performed based on the surgeon's discretion. Patients receiving combined phacoemulsification and PPV with or without SB can be included.
Group II: Pars plana vitrectomy with or without scleral buckleActive Control1 Intervention
Patients assigned to the PPV with or without SB group will undergo three-port PPV with or without SB. Surgery can be performed based on the surgeon's discretion. Patients receiving combined phacoemulsification and PPV with or without SB can be included.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,715 Total Patients Enrolled

Media Library

Intravitreal Topotecan (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05523869 — Phase 2
Proliferative Vitreoretinopathy Research Study Groups: Pars plana vitrectomy with or without scleral buckle, Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Proliferative Vitreoretinopathy Clinical Trial 2023: Intravitreal Topotecan Highlights & Side Effects. Trial Name: NCT05523869 — Phase 2
Intravitreal Topotecan (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523869 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
2023. "Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523869.
~20 spots leftby Feb 2025
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