What is the mechanism of action of this treatment?

The most common treatments for Proliferative Vitreoretinopathy (PVR) include agents with anti-inflammatory, anti-proliferative, and anti-fibrotic properties. Intravitreal topotecan, for example, works by reducing inflammation, inhibiting cell proliferation, and preventing fibrosis, which are critical in managing PVR. These mechanisms are important because PVR involves the growth of membranes on the retina that can contract and cause retinal detachment. By targeting inflammation, cell proliferation, and fibrosis, these treatments help to stabilize the retina, prevent further detachment, and improve visual outcomes for patients.

What side effects are associated with this type of intervention?

Intravitreal topotecan, used for its anti-inflammatory, anti-proliferative, and anti-fibrotic properties in treating Proliferative Vitreoretinopathy (PVR), has shown a favorable safety profile. Clinical use in doses ranging from 5-30 micrograms per injection has not reported adverse events, and preclinical studies in rabbits have not observed retinal toxicity. This suggests that intravitreal topotecan is a promising treatment option with minimal side effects for PVR.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Proliferative Vitreoretinopathy (PVR) in the provided context. However, treatments with anti-inflammatory, anti-proliferative, and anti-fibrotic properties, such as intravitreal topotecan, are being studied for their efficacy in managing PVR. Intravitreal topotecan has shown promise in cell cultures and is being investigated in clinical trials for its potential benefits in treating severe PVR in patients with rhegmatogenous retinal detachment.

What other types of research exist?

Promising novel alternatives to intravitreal topotecan for PVR patients include anti-VEGF agents like bevacizumab and pegaptanib, which have shown efficacy in managing neovascular conditions. Additionally, emerging therapies targeting angiogenic pathways, such as bispecific CrossMAbs, and other investigational agents like HIF-2 antagonists, may offer potential benefits. These alternatives should be discussed with a healthcare provider to determine the most appropriate treatment based on individual patient needs and the latest clinical evidence.

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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 up to 5 years

Awards & highlights

Summary

This trial is testing a medication called intravitreal topotecan, which is injected directly into the eye. It aims to help patients with severe proliferative vitreoretinopathy (PVR) and rhegmatogenous retinal detachment (RRD). The medication works by reducing inflammation, stopping abnormal cell growth, and preventing scarring inside the eye. Topotecan has been studied for its effectiveness and safety in treating retinoblastoma and has shown promising results in managing vitreous seeds.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Proliferative Vitreoretinopathy (PVR) include agents with anti-inflammatory, anti-proliferative, and anti-fibrotic properties. Intravitreal topotecan, for example, works by reducing inflammation, inhibiting cell proliferation, and preventing fibrosis, which are critical in managing PVR. These mechanisms are important because PVR involves the growth of membranes on the retina that can contract and cause retinal detachment. By targeting inflammation, cell proliferation, and fibrosis, these treatments help to stabilize the retina, prevent further detachment, and improve visual outcomes for patients.

Pharmacokinetic analysis of topotecan after intra-vitreal injection. Implications for retinoblastoma treatment.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

554 Previous Clinical Trials

454,241 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

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