Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Официальное название

Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Обзор

Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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 ABBV-6628
  Intravitreal injection
• Препарат SYFOVRE
  Intravitreal injection

Первичные конечные точки

• Number of Participants Experiencing Adverse Events [Срок оценки: Up to approximately 25 months]
• Number of Participants with Abnormal Change in Physical Examinations [Срок оценки: Up to approximately 25 months]
• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Срок оценки: Up to approximately 25 months]
• Change From Baseline in Electrocardiograms (ECGs) [Срок оценки: Up to approximately 25 months]
• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Срок оценки: Up to approximately 25 months]
• Change from baseline in Best Corrected Visual Acuity (BCVA) [Срок оценки: Up to approximately 25 months]
• Change in Slit lamp biomicroscopy assessment [Срок оценки: Up to approximately 25 months]
• Change in Intraocular pressure (IOP) [Срок оценки: Up to approximately 25 months]
• Change in Lens examination assessment [Срок оценки: Up to approximately 25 months]
• Change in Ophthalmoscopy assessment [Срок оценки: Up to approximately 25 months]

Критерии участия

Критерии включения

Stage 1 and Stage 2

-Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye.

Stage 1

• Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1
• Absence of choroidal neovascularization (CNV) in the study eye as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline/Day 1.

Stage 2

• Non-foveal GA with total lesion area of 1 to 7 DA (2.5 to 17.5 mm2); within 0.5 to 1.5 mm from fovea center in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1.
• Absence of CNV in both eyes as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline/Day 1.

Критерии исключения

Stage 1 and Stage 2

• History of recurrent or currently active ocular or intraocular inflammation (e.g., uveitis, endophthalmitis) in at least one eye at Screening and Baseline/Day 1.
• Active periocular, ocular, or intraocular infection in at least one eye at Baseline/Day 1.
• History or clinical signs of diabetic retinopathy, diabetic macular edema (DME), or any retinal vascular disease other than AMD in at least one eye at Screening and Baseline/Day 1.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Retina Partners Midwest, P.C. /ID# 262172 — Carmel
• Sierra Eye Associates /ID# 262142 — Reno
• Retina Research Institute of Texas /ID# 262141 — Abilene
• Retina Foundation of the Southwest /ID# 262479 — Dallas
• Retina Consultants - The Woodlands /ID# 262138 — The Woodlands

Идентификаторы

NCT: NCT07160179 · M24-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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