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

Официальное название

A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура Pars plana vitrectomy with or without scleral buckle
  Standard three-port pars plana vitrectomy with or without scleral buckle.

Первичные конечные точки

• Recurrent RRD secondary to PVR [Срок оценки: 6 months or last follow-up]

Вторичные конечные точки (5)

• Best corrected visual acuity [Срок оценки: 6 months or last follow-up]
• Proliferative vitreoretinopathy grade [Срок оценки: 6 months or last follow-up]
• Retinal reattachment rate [Срок оценки: 6 months or last follow-up]
• Complications [Срок оценки: 6 months or last follow-up]
• Best corrected visual acuity change from baseline [Срок оценки: 6 months or last follow-up]

Критерии участия

To be enrolled, patients need to meet the following inclusion criteria:

• 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.
• 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.

The following subject exclusion criteria will be considered:

• 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
• female patients of childbearing age (i.e. less than 50 years old).
• patients with pre-existing bone marrow suppression or cytopenias
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Sunnybrook Health Sciences Centre — Toronto
• St. Michael's Hospital — Toronto

Идентификаторы

NCT: NCT05523869 · TOPO-RD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗