15 Participants NeededMy employer runs this trial

Ixo-vec for Macular Degeneration

Recruiting at 11 trial locations
AS
Overseen ByAdverum Study Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Adverum Biotechnologies, Inc.
Must be taking: Anti-VEGF therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

AT

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

Able to comply with study procedures according to the Investigator's judgment
I am 50 years old or older.
Must agree to use an acceptable form of contraception
See 5 more

Exclusion Criteria

History of allergy, hypersensitivity, or contraindications to study products or excipients
I have received gene therapy before, except for Ixo-vec.
I have recently received anti-VEGF treatment.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of Ixo-vec in the contralateral eye

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, efficacy, and durability of the treatment

5 years
Regular visits as per study protocol

Monitoring

Assessment of clinical activity, including visual and anatomic outcomes, and need for supplemental anti-VEGF therapy

28 weeks

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

Group I: Ixo-vec dosing in Contralateral EyeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adverum Biotechnologies, Inc.

Lead Sponsor

Trials
10
Recruited
560+

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.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38152412/

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.