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RECRUITING Phase 3

Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

NCT06856577 · View on ClinicalTrials.gov ↗

Study Summary

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.

Interventions

  • GENETIC Ixo-vec
  • DRUG Aflibercept

Study Locations (20)

California

  • Adverum Clinical Site 109 — Bakersfield
  • Adverum Clinical Site 100 — Beverly Hills
  • Adverum Clinical Site 201 — Campbell
  • Adverum Clinical Site 172 — Encino
  • Adverum Clinical Site 169 — Fullerton
  • Adverum Clinical Site 224 — Huntington Beach
  • Adverum Clinical Site 215 — Redlands
  • Adverum Clinical Site 164 — Riverside
  • Adverum Clinical Site 140 — Sacramento
  • Adverum Clinical Site 212 — Sacramento
  • Adverum Clinical Site 175 — Santa Barbara
  • Adverum Clinical Site 202 — Torrance
  • Adverum Clinical Site 189 — Walnut Creek

Arizona

  • Adverum Clinical Site 223 — Gilbert
  • Adverum Clinical Site 178 — Phoenix
  • Adverum Clinical Site 126 — Phoenix
  • Adverum Clinical Site 229 — Scottsdale
  • Adverum Clinical Site 159 — Tucson

Arkansas

  • Adverum Clinical Site 198 — Springdale

Colorado

  • Adverum Clinical Site 200 — Denver

Trial Details

FieldValue
Enrollment Target 284 participants
Start Date 2025-02-28
Est. Completion 2030-11-23
Phase Phase 3

Sponsor

Adverum Biotechnologies

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06856577

The ClinicalTrials.gov registry entry for NCT06856577 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adverum Biotechnologies, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Neovascular Age-Related Macular Degeneration (nAMD) appearing as the primary indexed condition, and to 2 interventions — of which Ixo-vec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06856577 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06856577 about?

NCT06856577 is a clinical study titled "Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration". This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection o...

What is the current status of trial NCT06856577?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2025-02-28. Estimated completion is 2030-11-23.

What conditions does trial NCT06856577 study?

This clinical trial studies the following conditions: Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06856577?

The interventions under investigation include: Ixo-vec (GENETIC), Aflibercept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06856577?

This trial is sponsored by Adverum Biotechnologies, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06856577 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial