Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-6628: Stage 1-Cohort 1 | Experimental | Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. |
|
| ABBV-6628: Stage 1 -Cohort 2 | Experimental | Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1. |
|
| ABBV-6628: Stage 1 -Cohort 3 | Experimental | Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1. |
|
| ABBV-6628: Stage 1 -Cohort 4 | Experimental | Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. |
|
| ABBV-6628: Stage 2 | Experimental | Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. |
|
| SYFOVRE: Stage 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-6628 | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
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
Stage 2
Exclusion Criteria:
Stage 1 and Stage 2
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Partners Midwest, P.C. /ID# 262172 | Recruiting | Carmel | Indiana | 46032 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.
|
| SYFOVRE | Drug | Intravitreal injection |
|
| 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 |
| Retina Research Institute of Texas /ID# 262141 |
| Recruiting |
| Abilene |
| Texas |
| 79606-1224 |
| United States |
|
| Retina Foundation of the Southwest /ID# 262479 | Recruiting | Dallas | Texas | 75231 | United States |
|
| Retina Consultants - The Woodlands /ID# 262138 | Recruiting | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided