Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Intravitreal topotecan, Retinal detachment surgery.
- Кому может быть актуально
- Состояния в реестре: Retinal Detachment Rhegmatogenous, Proliferative Vitreoretinopathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат 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. - Процедура Retinal detachment surgery
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Первичные конечные точки
- Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy [Срок оценки: 6 months or last follow-up]
Вторичные конечные точки (6)
- Grade of proliferative vitreoretinopathy [Срок оценки: 6 months or last follow-up]
- Rate of primary retinal reattachment [Срок оценки: 6 months or last follow-up]
- Rate of final retinal reattachment [Срок оценки: 6 months or last follow-up]
- Best-corrected visual acuity [Срок оценки: 6 months or last follow-up]
- Change in best-corrected visual acuity from baseline [Срок оценки: 6 months or last follow-up]
- Rate of complications [Срок оценки: 6 months or last follow-up]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Канада · 2 центра
- St. Michael's Hospital — Toronto
- Sunnybrook Health Sciences Centre — Toronto
Идентификаторы
NCT: NCT06818721 · TOPO-PT