Health TrialsbyHealthPanel

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

ConditionsRetinal Detachment RhegmatogenousProliferative Vitreoretinopathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Retinal detachment surgery

    Procedure/Surgery

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

Treatment groups

394 Participants
are divided into 2 treatment groups
Group A: Intravitreal topotecan with retinal detachment surgeryExperimental treatment 2 interventions
Group B: Retinal detachment surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy

Time frame
6 months or last follow-up

Secondary outcomes

1

Grade of proliferative vitreoretinopathy

Time frame
6 months or last follow-up
2

Rate of primary retinal reattachment

Time frame
6 months or last follow-up
3

Rate of final retinal reattachment

Time frame
6 months or last follow-up
4

Best-corrected visual acuity

Time frame
6 months or last follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: