NCT07160179 · AbbVie
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
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ABBV-6628
Intravitreal injection
DRUG
SYFOVRE
Intravitreal injection
Primary outcome measures
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.
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.
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.
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).
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.
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)
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.
Change in Intraocular pressure (IOP)
Time frame: Up to approximately 25 months
Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer
Change in Lens examination assessment
Time frame: Up to approximately 25 months
Changes in Lens examination assessed by the physician will be assessed.
Change in Ophthalmoscopy assessment
Time frame: Up to approximately 25 months
Changes in Ophthalmoscopy assessed by the physician will be assessed.
Change in fundus autofluorescence (FAF) imaging assessed by Investigator
Time frame: Up to approximately 25 months
Fundus autofluorescence (FAF) imaging assessed by Investigator
Change in Retinal evaluation
Time frame: Up to approximately 25 months
Measured by color fundus photography (CFP) imaging assessed by Investigator
Change in spectral domain optical coherence tomography (SD-OCT)
Time frame: Up to approximately 25 months
Spectral domain optical coherence tomography (SD-OCT)
Change in Fluorescein angiography (FA) assessed by Investigator.
Time frame: Up to approximately 25 months
Fluorescein angiography (FA) assessed by Investigator
Change in choroidal neovascularization (CNV) assessed by Investigator.
Time frame: Up to approximately 25 months
Choroidal Neovascularization (CNV) assessed by Investigator.
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)
Maximum Serum Concentration (Cmax) of ABBV-6628
Time frame: Up to approximately 25 months
Cmax of ABBV-6628
Time to Cmax (Tmax) of ABBV-6628
Time frame: Up to approximately 25 months
Tmax of ABBV-6628
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
Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628
Time frame: Up to approximately 12 months
Ctrough of ABBV-6628
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 c
Where
- Carmel, Indiana
- Reno, Nevada
- Abilene, Texas
- Dallas, Texas
- The Woodlands, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations