Ixo-vec for Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gene therapy treatment called Ixo-vec for individuals with wet age-related macular degeneration (nAMD) in both eyes. Researchers aim to determine if treating the second eye with Ixo-vec is safe, effective, and long-lasting. Participants will receive the treatment in one eye and undergo monitoring for about five years to assess its effectiveness. This trial suits individuals with nAMD in both eyes who have shown improvement with previous treatments for this condition. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in eye disease treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving steroids in the treated eye or have used systemic immunosuppressive therapy or systemic anti-VEGF therapy within a certain period. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that Ixo-vec is likely to be safe for humans?
Research has shown that Ixo-vec, a gene therapy, has been well-tolerated in past studies for treating wet age-related macular degeneration (nAMD). In one study, patients who received Ixo-vec handled it well, with more than half not needing extra treatment for a year. Another study found that Ixo-vec was generally well-tolerated and helped maintain vision while reducing the need for additional anti-VEGF injections, commonly used for this condition. These results suggest that Ixo-vec is relatively safe for treating nAMD, though ongoing trials will provide more information.12345
Why do researchers think this study treatment might be promising for macular degeneration?
Unlike the standard treatments for macular degeneration, which typically include anti-VEGF injections like ranibizumab and aflibercept, Ixo-vec offers a novel approach by using gene therapy. This treatment delivers the gene for a therapeutic protein directly into the eye, potentially providing longer-lasting effects with a single administration. Researchers are excited about Ixo-vec because it could significantly reduce the frequency of treatments needed, making life easier for patients and possibly improving outcomes by maintaining more consistent therapeutic levels.
What evidence suggests that Ixo-vec might be an effective treatment for macular degeneration?
Research shows that Ixo-vec, a gene therapy, may help treat wet age-related macular degeneration (nAMD). Earlier studies found that Ixo-vec was safe and maintained stable vision for a year, with more than half of the patients not requiring additional treatments. It also improved eye health and significantly reduced the need for anti-VEGF injections, commonly used for nAMD. This treatment aims to lessen the frequent need for these injections, which can inconvenience patients. Overall, Ixo-vec has demonstrated lasting effectiveness and could offer a long-term solution for managing nAMD.12345
Who Is on the Research Team?
Adam Turpcu, PhD
Principal Investigator
Adverum Biotechnologies, Inc.
Are You a Good Fit for This Trial?
This trial is for adults aged 50 or older who have wet age-related macular degeneration (nAMD) in both eyes. It includes people who already had Ixo-vec gene therapy in one eye and those getting it for the first time. Participants must be able to receive treatment in their second eye.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of Ixo-vec in the contralateral eye
Follow-up
Participants are monitored for safety, efficacy, and durability of the treatment
Monitoring
Assessment of clinical activity, including visual and anatomic outcomes, and need for supplemental anti-VEGF therapy
What Are the Treatments Tested in This Trial?
Interventions
- Ixoberogene Soroparvovec (Ixo-vec)
Trial Overview
The study tests a single dose of Ixo-vec gene therapy given to the second eye of people with nAMD, tracking safety, effectiveness, and how long benefits last over about 5 years. Some may have had prior treatment in one eye; others are new to Ixo-vec.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adverum Biotechnologies, Inc.
Lead Sponsor
Citations
NCT07482176 | Efficacy and Safety Study of Ixoberogene ...
Ixo-vec is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF ...
Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene ... - IOVS
Ixo-vec was well tolerated and maintained visual and anatomic endpoints over 52 weeks with more than 50% of patients requiring no additional therapy.
a prospective, two-year, multicentre phase 1 study
Ixo-vec was generally well-tolerated, maintained vision, and improved anatomical outcomes in nAMD, with a substantial reduction in anti-VEGF ...
Adverum Biotechnologies
Adverum Biotechnologies Announces Positive Preliminary Efficacy and Safety Data from LUNA Phase 2 Trial of Ixo-vec in Patients with Wet AMD.
a prospective, two-year, multicentre phase 1 study
Ixo-vec was generally well-tolerated, maintained vision, and improved anatomical outcomes in nAMD, with a substantial reduction in anti-VEGF injections.
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