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

ConditionProliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients aged 18 years and older

patients who undergo PPV and/or SB for recurrent RRD due to PVR

patients with RRD and PVR grade C or D

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.

Disqualifiers

patients with a history of tractional or exudative retinal detachment

patients with severe non-proliferative or proliferative diabetic retinopathy

patients with other planned ocular surgery following PPV

patients with primary RRD

Trial design

Design model

Single group

Treatments tested in this trial

  • Intravitreal topotecan

    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

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intravitreal topotecan with pars plana vitrectomy with or without scleral buckleExperimental treatment 2 interventions
Group B: Pars plana vitrectomy with or without scleral buckleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrent RRD secondary to PVR

Time frame
6 months or last follow-up

Secondary outcomes

1

Best corrected visual acuity

Time frame
6 months or last follow-up
2

Proliferative vitreoretinopathy grade

Time frame
6 months or last follow-up
3

Retinal reattachment rate

Time frame
6 months or last follow-up
4

Complications

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
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