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

NCT07160179 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: M24-204
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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

Age-Related Macular Degeneration; Geographic Atrophy

Keywords

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

Outcome Measures

Primary Outcomes (20)

• Number of Participants Experiencing Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 25 months

• Number of Participants with Abnormal Change in Physical Examinations

  Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.

  Up to approximately 25 months

• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

  Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  Up to approximately 25 months

• Change From Baseline in Electrocardiograms (ECGs)

  12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

  Up to approximately 25 months

• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

  Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  Up to approximately 25 months

• Change from baseline in Best Corrected Visual Acuity (BCVA)

  BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (normal luminance and low luminance visual acuity)

  Up to approximately 25 months

• Change in Slit lamp biomicroscopy assessment

  Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.

  Up to approximately 25 months

• Change in Intraocular pressure (IOP)

  Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer

  Up to approximately 25 months

• Change in Lens examination assessment

  Changes in Lens examination assessed by the physician will be assessed.

  Up to approximately 25 months

• Change in Ophthalmoscopy assessment

  Changes in Ophthalmoscopy assessed by the physician will be assessed.

  Up to approximately 25 months

• Change in fundus autofluorescence (FAF) imaging assessed by Investigator

  Fundus autofluorescence (FAF) imaging assessed by Investigator

  Up to approximately 25 months

• Change in Retinal evaluation

  Measured by color fundus photography (CFP) imaging assessed by Investigator

  Up to approximately 25 months

• Change in spectral domain optical coherence tomography (SD-OCT)

  Spectral domain optical coherence tomography (SD-OCT)

  Up to approximately 25 months

• Change in Fluorescein angiography (FA) assessed by Investigator.

  Fluorescein angiography (FA) assessed by Investigator

  Up to approximately 25 months

• Change in choroidal neovascularization (CNV) assessed by Investigator.

  Choroidal Neovascularization (CNV) assessed by Investigator.

  Up to approximately 25 months

• Percentage of Participants with Clinically Significant Post-treatment Administration Assessment (study eye only) Findings as Assessed by the Investigator

  Post-treatment Administration Assessment (study eye only)

  Up to approximately 25 months

• Maximum Serum Concentration (Cmax) of ABBV-6628

  Cmax of ABBV-6628

  Up to approximately 25 months

• Time to Cmax (Tmax) of ABBV-6628

  Tmax of ABBV-6628

  Up to approximately 25 months

• Area Under the Concentration-Time Curve From zero to the last measurable Timepoint (AUC0-Tlast) of ABBV-6628

  AUC0-Tlast of ABBV-6628

  Up to approximately 25 months

• Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628

  Ctrough of ABBV-6628

  Up to approximately 12 months

Study Arms (6)

ABBV-6628: Stage 1-Cohort 1

EXPERIMENTAL

Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.

Drug: ABBV-6628

ABBV-6628: Stage 1 -Cohort 2

EXPERIMENTAL

Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.

Drug: ABBV-6628

ABBV-6628: Stage 1 -Cohort 3

EXPERIMENTAL

Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.

Drug: ABBV-6628

ABBV-6628: Stage 1 -Cohort 4

EXPERIMENTAL

Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.

Drug: ABBV-6628

ABBV-6628: Stage 2

EXPERIMENTAL

Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.

Drug: ABBV-6628

SYFOVRE: Stage 2

EXPERIMENTAL

Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.

Drug: SYFOVRE

Interventions

ABBV-6628 DRUG

Intravitreal injection

ABBV-6628: Stage 1 -Cohort 2; ABBV-6628: Stage 1 -Cohort 3; ABBV-6628: Stage 1 -Cohort 4; ABBV-6628: Stage 1-Cohort 1; ABBV-6628: Stage 2

SYFOVRE DRUG

Intravitreal injection

SYFOVRE: Stage 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

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

Carmel, Indiana, 46032, United States

RECRUITING

Retina Research Institute of Texas /ID# 262141

Abilene, Texas, 79606-1224, United States

RECRUITING

Retina Foundation of the Southwest /ID# 262479

Dallas, Texas, 75231, United States

RECRUITING

Retina Consultants - The Woodlands /ID# 262138

The Woodlands, Texas, 77384, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 8, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)