Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)

Официальное название

A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Обзор

Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат Surabgene Lomparvovec (ABBV-RGX-314)
  subretinal injection
• Препарат Ranibizumab Control
  intravitreal injection

Первичные конечные точки

• Annualized intravitreal anti-VEGF injection rate [Срок оценки: Up to Week 54]
• Number of Participants Experiencing Adverse Events [Срок оценки: Up to 5 years]

Вторичные конечные точки (2)

• Change from Baseline in best corrected visual acuity (BCVA) [Срок оценки: Up to 3 Years]
• Annualized intravitreal anti-VEGF injection rate [Срок оценки: Up to 3 Years]

Критерии участия

Критерии включения

• Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye.
• Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye

--CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2)

• Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)

Критерии исключения

• CNV or macular edema in the study eye that is secondary to any causes other than AMD
• Study eye with nAMD diagnosed > 4 years from Screening Visit 1
• Any retinal pigment epithelial detachment > 400 μm or any pigment epithelial detachment > 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.
• Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center
• Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 52 центра

• Barnet Dulaney Perkins Eye Centers /ID# 279265 — Mesa
• American Vision Partners /ID# 264615 — Sun City
• Retinal Diagnostic Center /ID# 263054 — Campbell
• The Retina Partners /ID# 263265 — Encino
• Retina Associates of Southern California /ID# 263056 — Huntington Beach
• Northern California Retina Vitreous Associates - Mountain View /ID# 263990 — Mountain View
• Eye Research Foundation /ID# 277345 — Newport Beach
• Retina Consultants of San Diego /ID# 264026 — Poway
• … и ещё 44 центра

Германия · 11 центров

• Universitaetsklinikum Freiburg /ID# 275449 — Freiburg im Breisgau
• Universitaetsklinikum Tuebingen /ID# 264283 — Tübingen
• … и ещё 9 центров

Испания · 11 центров

Список центров уточняется — проверьте первичный протокол.

Франция · 10 центров

• Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073 — Nice
• Hopital Edouard Herriot /ID# 265072 — Lyon
• Retine Gallien /ID# 265119 — Bordeaux
• Chu Bordeaux - Hopital Pellegrin /ID# 265123 — Bordeaux
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077 — Nantes
• Centre Hospitalier Intercommunal de Creteil /ID# 265080 — Créteil
• Centre Monticelli Paradis d'Ophtalmologie /ID# 265120 — Marseille
• Clinique Jules Verne /ID# 265076 — Nantes
• … и ещё 2 центра

Израиль · 8 центров

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Великобритания · 6 центров

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Италия · 5 центров

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Австрия · 4 центра

• Landesklinikum Mistelbach /ID# 275764 — Mistelbach
• Medizinische Universitaet Graz /ID# 264511 — Graz
• Medizinische Universitaet Innsbruck /ID# 264502 — Innsbruck
• Kepler Universitaetsklinikum GmbH /ID# 264493 — Linz

Болгария · 4 центра

• Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729 — Burgas
• OCIPSMAED St. Luka /ID# 275727 — Plovdiv
• Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730 — Sofia
• Medical Center -Vereya /ID# 275728 — Stara Zagora

Греция · 4 центра

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Хорватия · 3 центра

• Klinicki Bolnicki Centar Zagreb /ID# 276047 — Grad Zagreb
• Klinicka Bolnica Sveti Duh /ID# 275871 — Zagreb
• Specijalna bolnica Svjetlost /ID# 276051 — Zagreb

Венгрия · 3 центра

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Португалия · 3 центра

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Бельгия · 2 центра

• UZ Gent /ID# 261300 — Ghent
• Universitair Ziekenhuis Leuven /ID# 261302 — Leuven

Чехия · 2 центра

• Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663 — Prague
• Fakultni nemocnice Kralovske Vinohrady /ID# 264660 — Prague

Канада · 1 центр

• Retina Centre of Ottawa /ID# 263803 — Ottawa

Пуэрто-Рико · 1 центр

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Идентификаторы

NCT: NCT07007065 · M24-528 · 2024-512298-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗