Age-Related Macular Degeneration, Geographic Atrophy
Conditions
Keywords
Geographic Atrophy, Age-Related Macular Degeneration, ABBV-6628
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.
Interventions
DRUGABBV-6628
Intravitreal injection
DRUGSYFOVRE
Intravitreal injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change From Baseline in Electrocardiograms (ECGs) | 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 | 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) | 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 |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed