ABBV-6628 for Age-Related Macular Degeneration

Recruiting at 2 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Disqualifiers: Ocular inflammation, Ocular infection, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 22 months

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-6628 for individuals with geographic atrophy (GA), a serious condition linked to age-related macular degeneration (AMD) that affects vision. The trial aims to observe how this treatment behaves in the body and to identify any side effects. In the first stage, participants receive different doses of ABBV-6628. The second stage involves a comparison between ABBV-6628 and an existing treatment called SYFOVRE. Individuals diagnosed with GA due to AMD, who do not have certain other eye conditions, might be suitable for this study. As a Phase 1 and Phase 2 trial, the study focuses on understanding how ABBV-6628 works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the ABBV-6628 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABBV-6628, a new antibody treatment for geographic atrophy (GA), remains in the early testing stages. This means limited information exists about its safety in humans. The study will examine how the body processes the treatment and identify any side effects. Because it's in the early stages, less is known about its safety compared to treatments tested more thoroughly.

In contrast, SYFOVRE is an approved treatment for GA with a well-established safety record. It has undergone long-term safety testing and is generally well-tolerated. Some patients have reported mild side effects like eye discomfort, while more serious issues like retinal tears occur in less than 1% of cases.

Prospective trial participants should consider these factors and consult with their healthcare provider to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-6628 for age-related macular degeneration (AMD) because it offers a promising new approach compared to current treatments like anti-VEGF injections. ABBV-6628 potentially provides a novel mechanism of action, targeting pathways not addressed by existing therapies, which could lead to improved outcomes for patients. Additionally, ABBV-6628's dosing schedule, particularly with extended treatment durations as seen in Stage 2, might offer a more convenient and sustained therapeutic effect, which can be a significant advantage for those with AMD. Meanwhile, SYFOVRE is another investigational treatment in the trial, offering an alternative approach that could enhance treatment options and patient outcomes.

What evidence suggests that this trial's treatments could be effective for geographic atrophy secondary to age-related macular degeneration?

Research has shown that ABBV-6628 is an experimental drug aimed at treating geographic atrophy (GA), a serious type of age-related macular degeneration (AMD). It uses a special protein that attaches to specific parts of the body. Although limited information from human studies exists, early research focuses on understanding how the drug works in the body. In this trial, participants will receive ABBV-6628 in various cohorts to evaluate its effects.

SYFOVRE is another treatment option in this trial. Clinical trials have shown that it slows the growth of GA lesions. While it does not improve vision or restore lost sight, it can help slow the worsening of the condition. These findings suggest that both treatments might be helpful, although they work in different ways. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Participants must have a diagnosis of GA and be able to attend weekly visits at the hospital or clinic. The study excludes individuals who do not meet these criteria.

Inclusion Criteria

My eye condition is due to aging and has progressed to geographic atrophy.

My eye condition affects the central part of my vision and is within specific size limits without any blood vessel growth.

Exclusion Criteria

I have had or currently have eye inflammation or infection, and no diabetic eye diseases other than AMD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABBV-6628 or SYFOVRE for approximately 22 months with regular weekly visits for medical assessments, blood tests, and questionnaires

22 months

Regular weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-6628

Trial Overview The study tests ABBV-6628, an investigational drug for GA due to AMD. It involves two stages: Stage 1 has dose escalation of ABBV-6628 injections into the eye; Stage 2 compares ABBV-6628 with SYFOVRE, an approved GA treatment. Around 66 participants will join across approximately 27 US sites.

How Is the Trial Designed?

Group I: SYFOVRE: Stage 2 Experimental Treatment 1 Intervention

Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.

Group II: ABBV-6628: Stage 2 Experimental Treatment 1 Intervention

Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.

Group III: ABBV-6628: Stage 1-Cohort 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.

Group IV: ABBV-6628: Stage 1 -Cohort 4 Experimental Treatment 1 Intervention

Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.

Group V: ABBV-6628: Stage 1 -Cohort 3 Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.

Group VI: ABBV-6628: Stage 1 -Cohort 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07160179

NCT07160179 | Study to Assess the Adverse Events and ... ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular ...

2. trialx.com trialx.com/clinical-trials/listings/321539/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/

Age-Related Macular Degeneration ) ( NCT07160179 ) ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age ...

3. tipranks.com tipranks.com/news/company-announcements/abbvies-promising-study-on-abbv-6628-for-geographic-atrophy-what-investors-need-to-know

AbbVie's Promising Study on ABBV-6628 for Geographic ... ' The study aims to evaluate the safety and movement of the drug ABBV-6628 in the bodies of adults with geographic atrophy, a severe form of age ...

4. synapse.patsnap.com synapse.patsnap.com/drug/8ad47eedc76240d1ba30ed7c50d3e155

ABBV-6628 - Drug Targets, Indications, Patents ... ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration. 100 Clinical Results associated with ABBV-6628.

5. withpower.com withpower.com/clinical-trials/for-geographic-atrophy

Top Geographic Atrophy Clinical Trials | Power 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- ...

6. ctv.veeva.com ctv.veeva.com/study/study-to-assess-the-adverse-events-and-how-intravitreal-abbv-6628-moves-through-the-body-of-adult-pa

Study to Assess the Adverse Events and How Intravitreal ... ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800084433

ABBV 6628 - AdisInsight - Springer ABBV 6628 is an investigational monoclonal antibody fragment, being developed by AbbVie, for the treatment of age-related macular degeneration.