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NCT Number: NCT07160179

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

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.

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Key information

Conditions

Geographic Atrophy Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Retina Partners Midwest, P.C. /ID# 262172, Carmel, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-6628

Drug

Intravitreal injection

SYFOVRE

Drug

Intravitreal injection

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 25 months

    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.

  2. Number of Participants with Abnormal Change in Physical Examinations

    Time frame: Up to approximately 25 months

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

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

    Time frame: Up to approximately 25 months

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

  4. Change From Baseline in Electrocardiograms (ECGs)

    Time frame: Up to approximately 25 months

    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).

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

    Time frame: Up to approximately 25 months

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

  6. Change from baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: Up to approximately 25 months

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

  7. Change in Slit lamp biomicroscopy assessment

    Time frame: Up to approximately 25 months

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

  8. Change in Intraocular pressure (IOP)

    Time frame: Up to approximately 25 months

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

  9. Change in Lens examination assessment

    Time frame: Up to approximately 25 months

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

  10. Change in Ophthalmoscopy assessment

    Time frame: Up to approximately 25 months

    Changes in Ophthalmoscopy assessed by the physician will be assessed.

  11. Change in fundus autofluorescence (FAF) imaging assessed by Investigator

    Time frame: Up to approximately 25 months

    Fundus autofluorescence (FAF) imaging assessed by Investigator

  12. Change in Retinal evaluation

    Time frame: Up to approximately 25 months

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

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

    Time frame: Up to approximately 25 months

    Spectral domain optical coherence tomography (SD-OCT)

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

    Time frame: Up to approximately 25 months

    Fluorescein angiography (FA) assessed by Investigator

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

    Time frame: Up to approximately 25 months

    Choroidal Neovascularization (CNV) assessed by Investigator.

  16. 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

    Post-treatment Administration Assessment (study eye only)

  17. Maximum Serum Concentration (Cmax) of ABBV-6628

    Time frame: Up to approximately 25 months

    Cmax of ABBV-6628

  18. Time to Cmax (Tmax) of ABBV-6628

    Time frame: Up to approximately 25 months

    Tmax of ABBV-6628

  19. 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

    AUC0-Tlast of ABBV-6628

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

    Time frame: Up to approximately 12 months

    Ctrough of ABBV-6628

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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