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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

Purpose

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.

Conditions

Geographic Atrophy
Age-Related Macular Degeneration

Eligibility

Eligible Ages: Over 50 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ABBV-6628: Stage 1-Cohort 1	Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.	Drug: ABBV-6628 Intravitreal injection
Experimental ABBV-6628: Stage 1 -Cohort 2	Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.	Drug: ABBV-6628 Intravitreal injection
Experimental ABBV-6628: Stage 1 -Cohort 3	Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.	Drug: ABBV-6628 Intravitreal injection
Experimental ABBV-6628: Stage 1 -Cohort 4	Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.	Drug: ABBV-6628 Intravitreal injection
Experimental ABBV-6628: Stage 2	Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.	Drug: ABBV-6628 Intravitreal injection
Experimental SYFOVRE: Stage 2	Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.	Drug: SYFOVRE Intravitreal injection

Recruiting Locations

Retina Partners Midwest, P.C. /ID# 262172
Carmel 4255466, Indiana 4921868 46032

Retina Research Institute of Texas /ID# 262141
Abilene 4669635, Texas 4736286 79606-1224

Contact:
Site Coordinator
325-690-4414

Retina Foundation of the Southwest /ID# 262479
Dallas 4684888, Texas 4736286 75231

Contact:
Site Coordinator
214.363.3911

More Details

NCT ID: NCT07160179
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.