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Идёт набор NCT07275840

A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD

Фаза II С лечением Neovascular Age-related Macular Degeneration

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: IBI302 8mg dose.
Кому может быть актуально
Состояния в реестре: Neovascular Age-related Macular Degeneration. Базовые параметры: от 50 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
Китай
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

An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration

Обзор

This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.

Вмешательства

  • Препарат IBI302 8mg dose
    8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.

Первичные конечные точки

  • Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 [Срок оценки: Week52]
Вторичные конечные точки (12)
  • The changes in BCVA from baseline at each visit [Срок оценки: Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52]
  • Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 [Срок оценки: Week52]
  • Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 [Срок оценки: Week52]
  • The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 [Срок оценки: Week52]
  • Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 [Срок оценки: Week52]
  • Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline [Срок оценки: Week52]
  • Change in CNV leakage area on FFA at week 52 compared to baseline [Срок оценки: Week52]
  • Proportion of participants with new-onset MA on OCT at Week 52 [Срок оценки: Week52]
  • Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 [Срок оценки: Week52]
  • Change in MA area on OCT from baseline at Week 52 [Срок оценки: Week52]
  • Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 [Срок оценки: Week52]
  • The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE) [Срок оценки: From baseline through Week 52]

Критерии участия

Критерии включения

  • Have signed an informed consent form before participating in the research.
  • Male or female individuals aged 50 or above at the time of signing the informed consent form;
  • Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
  • At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).

Критерии исключения

  • According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;
  • The study eye has uncontrollable glaucoma;
  • There is an active intraocular or periocular infection or inflammation in either eye;
  • The non-study eye has severe visual function disorders;
  • Within 90 days before baseline, the study eye had received anti-VEGF treatment;
  • Within 90 days before baseline, the study eye had received anti-complement treatment;
  • At any time before baseline, the study eye had received IBI302 treatment;
  • Uncontrollable hypertension;
  • Glycated hemoglobin (HbA1c) > 10.0% within 28 days prior to screening;
  • Other exclusion criteria set by protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai general hospital — Шанхай

Идентификаторы

NCT: NCT07275840 · CIBI302A203

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗