ABBV-6628 for Age-Related Macular Degeneration
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.12345Why 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.13567Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABBV-6628 or SYFOVRE for approximately 22 months with regular weekly visits for medical assessments, blood tests, and questionnaires
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
6
Treatment groups
Experimental Treatment
Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.
Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.
Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.
Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.
Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.
Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
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 ...
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 ...
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 ...
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.
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-paStudy 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 ...
ABBV 6628 - AdisInsight - Springer
ABBV 6628 is an investigational monoclonal antibody fragment, being developed by AbbVie, for the treatment of age-related macular degeneration.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.