Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

NCT ID: NCT05523869

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2026-02-28

Brief Summary

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. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.

Conditions

Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle

Group Type: EXPERIMENTAL

Intravitreal topotecan

Intervention Type: DRUG

Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.

Pars plana vitrectomy with or without scleral buckle

Intervention Type: PROCEDURE

Standard three-port pars plana vitrectomy with or without scleral buckle.

Pars plana vitrectomy with or without scleral buckle

Group Type: ACTIVE_COMPARATOR

Pars plana vitrectomy with or without scleral buckle

Intervention Type: PROCEDURE

Standard three-port pars plana vitrectomy with or without scleral buckle.

Interventions

Intravitreal topotecan

Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.

Intervention Type: DRUG

Pars plana vitrectomy with or without scleral buckle

Standard three-port pars plana vitrectomy with or without scleral buckle.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rajeev Muni, MD

Role: CONTACT

rajeev.muni@utoronto.ca

416-867-7411

Marko Popovic, MD

Role: CONTACT

marko.popovic@mail.utoronto.ca

416-867-7411

Facility Contacts

Peter Kertes, MD

Role: primary

416-480-4244

Rajeev Muni

Role: primary

(416) 867-7411

Other Identifiers

TOPO-RD

Identifier Type: -

Identifier Source: org_study_id