Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment

NCT ID: NCT06818721

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-04-30

Brief Summary

Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.

Detailed Description

Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.

Conditions

Retinal Detachment Rhegmatogenous; Proliferative Vitreoretinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intravitreal topotecan with retinal detachment surgery

Intravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively.

Group Type: EXPERIMENTAL

Intravitreal topotecan

Intervention Type: DRUG

Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections.

Retinal detachment surgery

Intervention Type: PROCEDURE

Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).

Retinal detachment surgery

Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan.

Group Type: ACTIVE_COMPARATOR

Retinal detachment surgery

Intervention Type: PROCEDURE

Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).

Interventions

Intravitreal topotecan

Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections.

Intervention Type: DRUG

Retinal detachment surgery

Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).

Intervention Type: PROCEDURE

Other Intervention Names

Topotecan; Pars plana vitrectomy; Pneumatic retinopexy; Scleral buckling

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 years and older

2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment

3. Patients who are voluntarily able and willing to participate

Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.

Exclusion Criteria

1. Patients with a history of exudative retinal detachment

2. Patients with severe non-proliferative or proliferative diabetic retinopathy

3. Patients with other planned ocular surgery following pars plana vitrectomy

4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study

5. Patients with pre-existing bone marrow suppression or cytopenias

6. Patients with pre-existing interstitial lung disease

• 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

St. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Rajeev H Muni, MD MSc FRCSC

Role: CONTACT

rajeev.muni@utoronto.ca

416-867-7411

Marko M Popovic, MD MPH FRCSC

Role: CONTACT

marko.popovic@mail.utoronto.ca

416-867-7411

Facility Contacts

Rajeev H Muni, MD MSc FRCSC

Role: primary

rajeev.muni@utoronto.ca

416-867-7411

Rajeev H Muni, MD MSc FRCSC

Role: backup

Peter J Kertes, MD CM FRCSC

Role: primary

peter.kertes@sunnybrook.ca

416-480-4244

Peter J Kertes, MD CM FRCSC

Role: backup

Other Identifiers

TOPO-PT

Identifier Type: -

Identifier Source: org_study_id