Geographic AtrophyPhase 1/2NCT07160179
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
A Phase 1/2 study testing ABBV-6628 and SYFOVRE in people with Geographic Atrophy and Age-Related Macular Degeneration, run by AbbVie at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy, Age-Related Macular Degeneration
- What is being tested?
- ABBV-6628 and SYFOVRE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Aug 2025to Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Retina Research Institute of Texas /ID# 262141
Abilene, Texas, 79606-1224
Site Coordinator, 325-690-4414
- Recruiting
Retina Partners Midwest, P.C. /ID# 262172
Carmel, Indiana, 46032
- Recruiting
Retina Foundation of the Southwest /ID# 262479
Dallas, Texas, 75231
Site Coordinator, 214.363.3911
- Recruiting
Sierra Eye Associates /ID# 262142
Reno, Nevada, 89502
- Recruiting
Retina Consultants - The Woodlands /ID# 262138
The Woodlands, Texas, 77384
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects 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.
Read more
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.
- Being tested
- ABBV-6628, SYFOVRE
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration, ABBV-6628
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-6628Drug
Intravitreal injection
SYFOVREDrug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| ABBV-6628: Stage 1-Cohort 1 | Experimental | Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. Receives: 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. Receives: 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. Receives: Drug: ABBV-6628 |
| ABBV-6628: Stage 1 -Cohort 4 | Experimental | Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. Receives: Drug: ABBV-6628 |
| ABBV-6628: Stage 2 | Experimental | Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. Receives: Drug: ABBV-6628 |
| SYFOVRE: Stage 2 | Experimental | Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up. Receives: Drug: SYFOVRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Up to approximately 25 months
Change in Slit lamp biomicroscopy assessment
Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.
Measured: Up to approximately 25 months
Change in Intraocular pressure (IOP)
Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer
Measured: Up to approximately 25 months
Change in Lens examination assessment
Changes in Lens examination assessed by the physician will be assessed.
Measured: Up to approximately 25 months
Change in Ophthalmoscopy assessment
Changes in Ophthalmoscopy assessed by the physician will be assessed.
Measured: Up to approximately 25 months
Change in fundus autofluorescence (FAF) imaging assessed by Investigator
Fundus autofluorescence (FAF) imaging assessed by Investigator
Measured: Up to approximately 25 months
Change in Retinal evaluation
Measured by color fundus photography (CFP) imaging assessed by Investigator
Measured: Up to approximately 25 months
Change in spectral domain optical coherence tomography (SD-OCT)
Spectral domain optical coherence tomography (SD-OCT)
Measured: Up to approximately 25 months
Change in Fluorescein angiography (FA) assessed by Investigator.
Fluorescein angiography (FA) assessed by Investigator
Measured: Up to approximately 25 months
Change in choroidal neovascularization (CNV) assessed by Investigator.
Choroidal Neovascularization (CNV) assessed by Investigator.
Measured: 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)
Measured: Up to approximately 25 months
Maximum Serum Concentration (Cmax) of ABBV-6628
Cmax of ABBV-6628
Measured: Up to approximately 25 months
Time to Cmax (Tmax) of ABBV-6628
Tmax of ABBV-6628
Measured: 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
Measured: Up to approximately 25 months
Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628
Ctrough of ABBV-6628
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start13 Aug 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160179
- Sponsor's protocol ID
- M24-204
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07160179
- Acronym / sponsor ID
- M24-204
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration, ABBV-6628
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ABBV-6628: Stage 1-Cohort 1 | Experimental | Drug: ABBV-6628Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. |
| ABBV-6628: Stage 1 -Cohort 2 | Experimental | Drug: ABBV-6628Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1. |
| ABBV-6628: Stage 1 -Cohort 3 | Experimental | Drug: ABBV-6628Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1. |
| ABBV-6628: Stage 1 -Cohort 4 | Experimental | Drug: ABBV-6628Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. |
| ABBV-6628: Stage 2 | Experimental | Drug: ABBV-6628Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. |
| SYFOVRE: Stage 2 | Experimental | Drug: SYFOVREParticipants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-6628Intravitreal injection | Drug | 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 |
| SYFOVREIntravitreal injection | Drug | SYFOVRE: Stage 2 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
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A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABBV-6628 and SYFOVRE in people with Geographic Atrophy and Age-Related Macular Degeneration, run by AbbVie at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (time frame: Up to approximately 25 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.