Recruiting
Phase 1
Phase 2

ABBV-6628

Sponsor:

AbbVie

Code:

NCT07160179

Conditions

Geographic Atrophy

Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

ABBV-6628

SYFOVRE

Study Details

Brief summary:

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

Study ID

NCT07160179

Start date

Aug 13, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ABBV-6628

Intravitreal injection

SYFOVRE

Intravitreal injection

Primary outcome measure

  • 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 ]
  • Change in fundus autofluorescence (FAF) imaging assessed by Investigator [ Time Frame: Up to approximately 25 months ]
  • Change in Retinal evaluation [ Time Frame: Up to approximately 25 months ]
  • Change in spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Up to approximately 25 months ]
  • Change in Fluorescein angiography (FA) assessed by Investigator. [ Time Frame: Up to approximately 25 months ]
  • Change in choroidal neovascularization (CNV) assessed by Investigator. [ Time Frame: Up to approximately 25 months ]
  • Percentage of Participants with Clinically Significant Post-treatment Administration Assessment (study eye only) Findings as Assessed by the Investigator [ Time Frame: Up to approximately 25 months ]
  • Maximum Serum Concentration (Cmax) of ABBV-6628 [ Time Frame: Up to approximately 25 months ]
  • Time to Cmax (Tmax) of ABBV-6628 [ Time Frame: Up to approximately 25 months ]
  • Area Under the Concentration-Time Curve From zero to the last measurable Timepoint (AUC0-Tlast) of ABBV-6628 [ Time Frame: Up to approximately 25 months ]
  • Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628 [ Time Frame: Up to approximately 12 months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Retina Partners Midwest, P.C. /ID# 262172

Recruiting

Carmel, Indiana, United States, 46032

Sierra Eye Associates /ID# 262142

Recruiting

Reno, Nevada, United States, 89502

Retina Research Institute of Texas /ID# 262141

Recruiting

Abilene, Texas, United States, 79606-1224

Contacts

Site Coordinator

325-690-4414

Retina Foundation of the Southwest /ID# 262479

Recruiting

Dallas, Texas, United States, 75231

Contacts

Site Coordinator

214.363.3911

Retina Consultants - The Woodlands /ID# 262138

Recruiting

The Woodlands, Texas, United States, 77384

More Information

Sponsor

AbbVie

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Geographic Atrophy
  • Age-Related Macular Degeneration
  • ABBV-6628

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-13.