Actively Recruiting

Phase 1
Phase 2
Age: 50Years +
All Genders
NCT07160179

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

Led by AbbVie · Updated on 2026-02-12

66

Participants Needed

4

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with geographic atrophy secondary to age-related macular degeneration in the study eye
  • For Stage 1: Foveal or non-foveal geographic atrophy with total lesion area ≥ 0.5 DA (1.25 mm2) in the study eye
  • For Stage 1: No choroidal neovascularization in the study eye
  • For Stage 2: Non-foveal geographic atrophy with total lesion area of 1 to 7 DA (2.5 to 17.5 mm2) within 0.5 to 1.5 mm from the fovea center in the study eye
  • For Stage 2: No choroidal neovascularization in both eyes
Not Eligible

You will not qualify if you...

  • History of recurrent or active ocular or intraocular inflammation such as uveitis or endophthalmitis in at least one eye
  • Active periocular, ocular, or intraocular infection in at least one eye
  • History or signs of diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases besides age-related macular degeneration in at least one eye

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Retina Partners Midwest, P.C. /ID# 262172

Carmel, Indiana, United States, 46032

Actively Recruiting

2

Retina Research Institute of Texas /ID# 262141

Abilene, Texas, United States, 79606-1224

Actively Recruiting

3

Retina Foundation of the Southwest /ID# 262479

Dallas, Texas, United States, 75231

Actively Recruiting

4

Retina Consultants - The Woodlands /ID# 262138

The Woodlands, Texas, United States, 77384

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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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 | DecenTrialz