Using intravitreal topotecan to treat severe retinal detachment complications
A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
This study is testing if a new injection of topotecan can help people with severe retinal detachment complications who haven't had success with regular surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05523869 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of intravitreal topotecan, a drug known for its anti-inflammatory and anti-fibrotic properties, in patients suffering from proliferative vitreoretinopathy (PVR) associated with rhegmatogenous retinal detachment (RRD). The study aims to assess the efficacy and safety of this treatment in individuals who have previously undergone standard surgical interventions for RRD but have experienced re-detachment. Participants will receive intravitreal topotecan injections alongside pars plana vitrectomy and/or scleral buckle procedures. The trial is designed to provide insights into a potentially effective alternative for patients with a poor visual prognosis due to severe PVR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recurrent RRD due to PVR and have previously failed standard surgical treatments.
Not a fit: Patients with PVR grade A or B, or those who have not undergone prior vitreoretinal surgery for RRD, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual outcomes for patients with severe PVR following retinal detachment.
How similar studies have performed: While intravitreal topotecan has shown promise in cell cultures for treating PVR, this specific application in a clinical setting is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
To be enrolled, patients need to meet the following inclusion criteria: 1. patients aged 18 years and older 2. patients who undergo PPV and/or SB for recurrent RRD due to PVR 3. patients with RRD and PVR grade C or D 4. 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, including pneumatic retinopexy, pars plana vitrectomy and/or scleral buckle, and to have clinical documentation supporting re-detachment of the retina after one or more vitreoretinal surgeries for RRD in the same eye. This cohort of patients is expected to have an extremely guarded visual prognosis and visual potential. 5. 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. The following subject exclusion criteria will be considered: 1. patients with a history of tractional or exudative retinal detachment 2. patients with severe non-proliferative or proliferative diabetic retinopathy 3. patients with other planned ocular surgery following PPV 4. patients with primary RRD 5. female patients of childbearing age (i.e. less than 50 years old). 6. patients with pre-existing bone marrow suppression or cytopenias 7. 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.
Where this trial is running
Toronto, Ontario and 1 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Rajeev Muni, MD
- Email: rajeev.muni@utoronto.ca
- Phone: 416-867-7411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.