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
- Conditions
- Geographic AtrophyAge-Related Macular Degeneration
- Interventions
- Drug: ABBV-6628
- Registration Number
- NCT07160179
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ABBV-6628: Stage 1-Cohort 1 ABBV-6628 Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. ABBV-6628: Stage 1 -Cohort 3 ABBV-6628 Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1. ABBV-6628: Stage 1 -Cohort 2 ABBV-6628 Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1. ABBV-6628: Stage 1 -Cohort 4 ABBV-6628 Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. ABBV-6628: Stage 2 ABBV-6628 Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. SYFOVRE: Stage 2 SYFOVRE Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events 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 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 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.
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Up to approximately 25 months 12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed 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 Change from Baseline in Best Corrected Visual Acuity (BCVA) 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 Up to approximately 25 months Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.
Change in Intraocular pressure (IOP) Up to approximately 25 months Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer
Change in Lens examination assessment Up to approximately 25 months Changes in Lens examination assessed by the physician will be assessed.
Change in Ophthalmoscopy assessment Up to approximately 25 months Changes in Ophthalmoscopy assessed by the physician will be assessed.
Change in fundus autofluorescence (FAF) imaging assessed by Investigator Up to approximately 25 months Fundus autofluorescence (FAF) imaging assessed by Investigator
Change in Retinal evaluation Up to approximately 25 months Measured by color fundus photography (CFP) imaging assessed by Investigator
Change in spectral domain optical coherence tomography (SD-OCT) Up to approximately 25 months Spectral domain optical coherence tomography (SD-OCT)
Change in Fluorescein angiography (FA) assessed by Investigator. Up to approximately 25 months Fluorescein angiography (FA) assessed by Investigator
Change in choroidal neovascularization (CNV) assessed by Investigator. 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 Up to approximately 25 months Post-treatment Administration Assessment (study eye only)
Maximum Serum Concentration (Cmax) of ABBV-6628 Up to approximately 25 months Cmax of ABBV-6628
Time to Cmax (Tmax) of ABBV-6628 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 Up to approximately 25 months AUC0-Tlast of ABBV-6628
Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628 Up to approximately 12 months Ctrough of ABBV-6628
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Retina Partners Midwest, P.C. /ID# 262172
🇺🇸Carmel, Indiana, United States
Retina Foundation of the Southwest /ID# 262479
🇺🇸Dallas, Texas, United States
Retina Partners Midwest, P.C. /ID# 262172🇺🇸Carmel, Indiana, United States