Eye injections of ABBV-6628 for geographic atrophy from age-related macular degeneration
Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This trial will test whether intravitreal ABBV-6628 is safe and how the drug moves through the body in adults aged 50 and older with geographic atrophy from AMD.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 4 sites (Carmel, Indiana and 3 other locations) |
| Trial ID | NCT07160179 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional study enrolls about 66 adults with geographic atrophy (GA) secondary to age-related macular degeneration to characterize adverse events and the drug's pharmacokinetics after intravitreal ABBV-6628 injections. Stage 1 participants are assigned to one of four treatment arms and Stage 2 participants to one of two arms, with different dosing regimens across groups. Eligibility requires confirmed GA lesion size and absence of choroidal neovascularization, with central reading center confirmation before dosing. Participants attend regular eye visits for imaging, safety monitoring, and pharmacokinetic sampling at approximately 27 U.S. sites.
Who should consider this trial
Good fit: Adults aged 50 years or older with confirmed geographic atrophy from AMD in the study eye who meet the trial's lesion-size and no-choroidal-neovascularization criteria are eligible.
Not a fit: People with active choroidal neovascularization, lesion sizes or locations outside the study's required ranges, or who cannot tolerate intravitreal injections are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, ABBV-6628 could offer a new treatment option that slows progression of geographic atrophy and helps preserve vision.
How similar studies have performed: Other complement-targeting therapies (for example, pegcetacoplan/SYFOVRE) have shown some ability to slow GA lesion growth, but ABBV-6628 is a different investigational agent and remains earlier-phase.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Carmel, Indiana and 3 other locations
- Retina Partners Midwest, P.C. /ID# 262172 — Carmel, Indiana, United States (Recruiting)
- Retina Research Institute of Texas /ID# 262141 — Abilene, Texas, United States (Recruiting)
- Retina Foundation of the Southwest /ID# 262479 — Dallas, Texas, United States (Recruiting)
- Retina Consultants - The Woodlands /ID# 262138 — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.