BridgeMD
New treatment option for Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Official title Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
ClinicalTrials.gov ID: NCT05523869
What this study is testing
What is Intravitreal topotecan?
Intravitreal topotecan is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for proliferative vitreoretinopathy in rhegmatogenous retinal detachment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be enrolled, patients need to meet the following
- 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 have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to...
You likely can't join if
- will be considered:
- 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).
See the full eligibility criteria
- To be enrolled, patients need to meet the following
- 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 have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to have previously received at least one vitreoretinal surgery for RRD...
- 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...
- will be considered:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.