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

NCT06818721 | Not Yet Recruiting Phase 2

• 1 other identifier: TOPO-PT
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinal Detachment Rhegmatogenous; Proliferative Vitreoretinopathy

Keywords

topotecan; proliferative vitreoretinopathy; rhegmatogenous retinal detachment

Outcome Measures

Primary Outcomes (1)

• Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy

  6 months or last follow-up

Secondary Outcomes (6)

• Grade of proliferative vitreoretinopathy

  6 months or last follow-up

• Rate of primary retinal reattachment

  6 months or last follow-up

• Rate of final retinal reattachment

  6 months or last follow-up

• Best-corrected visual acuity

  6 months or last follow-up

• Change in best-corrected visual acuity from baseline

  6 months or last follow-up

Study Arms (2)

Intravitreal topotecan with retinal detachment surgery

EXPERIMENTAL

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.

Drug: Intravitreal topotecan; Procedure: Retinal detachment surgery

Retinal detachment surgery

ACTIVE COMPARATOR

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

Procedure: Retinal detachment surgery

Interventions

Intravitreal topotecan 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.

Also known as: Topotecan

Intravitreal topotecan with retinal detachment surgery

Retinal detachment surgery PROCEDURE

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

Also known as: Pars plana vitrectomy, Pneumatic retinopexy, Scleral buckling

Intravitreal topotecan with retinal detachment surgery; Retinal detachment surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older
• Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
• 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.

You may not qualify if:

• Patients with a history of exudative retinal detachment
• Patients with severe non-proliferative or proliferative diabetic retinopathy
• Patients with other planned ocular surgery following pars plana vitrectomy
• Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
• Patients with pre-existing bone marrow suppression or cytopenias
• Patients with pre-existing interstitial lung disease

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

Topotecan; Scleral Buckling

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Rajeev H Muni, MD MSc FRCSC

CONTACT

416-867-7411; rajeev.muni@utoronto.ca

Marko M Popovic, MD MPH FRCSC

CONTACT

416-867-7411; marko.popovic@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)