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NCT06856577 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD) and Wet AMD, sponsored by Adverum Biotechnologies.

Recruiting
Registry status
Phase 3
Development phase
284
Enrollment target
20
Study locations

NCT06856577: Recruiting Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD) and Wet AMD, sponsored by Adverum Biotechnologies.

NCT06856577 is a Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD) and Wet AMD that is actively recruiting participants, run by Adverum Biotechnologies. The registered enrollment target is 284 participants, above the 177-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (60% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06856577, a Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD) and Wet AMD, is actively recruiting participants, sponsored by Adverum Biotechnologies.

RECRUITING
Registry status
Phase 3
Development phase
284 participants
Enrollment target
20
Study locations

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.

Primary Outcome

BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.

Conditions Studied

Neovascular Age-related Macular Degeneration (nAMD) Wet AMD

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
Adverum Biotechnologies

10 total trials

What NCT06856577 shows while recruiting

NCT06856577 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (60% higher).

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.

NCT06856577 names 20 study sites across 4 states, led by California, Arizona, Arkansas.

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.

What interventions are being tested in trial NCT06856577?

The interventions under investigation include: Ixo-vec (GENETIC), Aflibercept (DRUG).

Who is sponsoring clinical trial NCT06856577?

This trial is sponsored by Adverum Biotechnologies, which has 10 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Neovascular Age-related Macular Degeneration (nAMD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06856577's enrollment target sits among peer trials

284 2nd of 9 higher than 7 of 9 other Neovascular Age-related Macular Degeneration (nAMD) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration (nAMD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06856577

Source: ClinicalTrials.gov NCT06856577, the US trial registry maintained by the National Library of Medicine. NCT06856577 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.