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

Part of paid clinical trials in Carmel, Indiana.

Sponsor
AbbVie
Study ID
NCT07160179
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-6628 — DRUG
    Intravitreal injection
  • SYFOVRE — DRUG
    Intravitreal injection

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Feb 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 25 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Retina Partners Midwest, P.C. /ID# 262172CarmelIndiana46032-
Retina Research Institute of Texas /ID# 262141AbileneTexas79606-1224
Site Coordinator
325-690-4414
Retina Foundation of the Southwest /ID# 262479DallasTexas75231
Site Coordinator
214.363.3911
Retina Consultants - The Woodlands /ID# 262138The WoodlandsTexas77384-

Find similar trials in Carmel, IN

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina Partners Midwest, P.C.· Carmel, INRetina Research Institute of Texas· Abilene, TXRetina Foundation of the Southwest· Dallas, TXRetina Consultants - The Woodlands· The Woodlands, TX

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