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

Official title

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

Overview

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.

Interventions

• Drug ABBV-6628
  Intravitreal injection
• Drug SYFOVRE
  Intravitreal injection

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 5 centers

• 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

Identifiers

NCT: NCT07160179 · M24-204

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗