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Набор по приглашению NCT05296447

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

Фаза II С лечением Diabetic Retinopathy, DR

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: Standard of Care, Aflibercept.
Кому может быть актуально
Состояния в реестре: Diabetic Retinopathy, DR. Базовые параметры: Без ограничений · 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
США
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

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema

Обзор

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.

Вмешательства

  • Препарат Standard of Care
    Standard of Care
  • Препарат Aflibercept
    Injection

Первичные конечные точки

  • Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) [Срок оценки: 5 years inclusive of the parent study]
Вторичные конечные точки (12)
  • Incidences of non-ocular AEs and any Adverse Events of Special Interest [Срок оценки: 5 years, inclusive to the parent study]
  • Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography [Срок оценки: 5 years, inclusive of the parent study]
  • Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA [Срок оценки: 5 years, inclusive to the parent study]
  • Proportion of participants gaining or losing ≥ 5, 10, and 15 letters in BCVA compared with baseline (ie, prior to ABBV-RGX-314 administration in the parent study) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT [Срок оценки: 5 years, inclusive to the parent study]
  • Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA [Срок оценки: 5 years, inclusive to the parent study]
  • Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Срок оценки: 5 years, inclusive to the parent study]
  • Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Срок оценки: 5 years, inclusive to the parent study]

Критерии участия

Критерии включения

  • Must provide written, signed informed consent for this study
  • Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study
  • Must be willing and able to comply with all study procedures

Критерии исключения

  • None

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
Лечение

Центры проведения

США · 20 центров
  • Retinal Research Institute, LLC — Phoenix
  • California Retina Consultants — Bakersfield
  • Retina-Vitreous Associates Medical Group — Beverly Hills
  • Retinal Diagnostic Center — Los Angeles
  • Northern California Retina Vitreous Associates Medical Group Inc — Mountain View
  • California Eye Specialists Medical Group, Inc — Pasadena
  • Retina Consultants San Diego — Poway
  • California Retina Consultants CRC — Santa Barbara
  • … и ещё 12 центров

Идентификаторы

NCT: NCT05296447 · RGX-314-5201 (M23-420) · M23-420

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗