Eye injections of ABBV-6628 for geographic atrophy from age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Retina Partners Midwest, P.C. /ID# 262172
  Carmel, Indiana, United States Recruiting
• Sierra Eye Associates /ID# 262142
  Reno, Nevada, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.