Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

Официальное название

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration

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 nAMD 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 up to 5 years after 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 Ranibizumab
  Injection

Первичные конечные точки

• Incidences of ocular Adverse Events and any Serious Adverse Events [Срок оценки: 5 years inclusive of parent study]

Вторичные конечные точки (9)

• Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest [Срок оценки: 5 years inclusive of parent study]
• Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints [Срок оценки: 5 years inclusive of parent study]
• Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints [Срок оценки: 5 years inclusive of parent study]
• Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5 [Срок оценки: 5 years inclusive of parent study]
• Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 [Срок оценки: 5 years inclusive of parent study]
• Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 [Срок оценки: 5 years inclusive of parent study]
• Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 [Срок оценки: 5 years inclusive of parent study]
• Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 [Срок оценки: 5 years inclusive of parent study]
• Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5 [Срок оценки: 5 years inclusive of 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 in the treatment of nAMD 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

1\. 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 · 16 центров

• Retinal Research Institute, LLC — Phoenix
• California Retina Consultants — Bakersfield
• Retina-Vitreous Associates Medical Group — Beverly Hills
• Northern California Retina Vitreous Associates Medical Group Inc — Mountain View
• Retina Consultants San Diego — Poway
• California Retina Consultants — Santa Barbara
• Southeast Retina Center PC — Augusta
• Johns Hopkins University — Baltimore
• … и ещё 8 центров

Идентификаторы

NCT: NCT05210803 · RGX-314-5102 (M23-421) · M23-421

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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