Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

Официальное название

Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial

Обзор

Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)

Вмешательства

• Препарат Conbercept
  Administered as an intravitreal injection

Первичные конечные точки

• Percentage of participants with absence of active ROP and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment [Срок оценки: Week 24]

Вторичные конечные точки (5)

• Percentage of participants with effective single intravitreal injection treatment [Срок оценки: Week 24]
• Percentage of participants having reactivation at or before week 24 [Срок оценки: Week 24]
• Percentage of participants with complete vascularization of the peripheral retina at or before week 24 [Срок оценки: Week 24]
• Percentage of participants requiring repeated intervention at or before week 24 [Срок оценки: Week 24]
• Percentage of participants requiring interventions with a second modality for ROP at or before week 24 [Срок оценки: Week 24]

Критерии участия

Критерии включения

• Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age
• Bilateral type 1 ROP with one of the following retinal findings in each eye
• Zone I, stage 1+, 2+, 3+/- disease, or
• Zone II, stage 2+, 3+, disease, or
• A-ROP

Критерии исключения

• Preterm infants with stage 4 or 5 ROP in one or both eyes
• Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy
• Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
• Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
• Have active ocular infection within 5 days before or on the day of first investigational treatment
• Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
• Have any contraindication for intravitreal injection clearly stated in the instructions
• Have any ocular structural abnormality that may affect efficacy assessments
• Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function
• Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University — Сиань
• Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University — Сиань
• Department of Ophthalmology, Xianyang Rainbow Hospital — Xianyang

Идентификаторы

NCT: NCT06717412 · KY20242291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗