Using intravitreal topotecan to treat severe retinal detachment complications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.