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NCT05536973 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]

A Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Adverum Biotechnologies.

Active
Registry status
Phase 2
Development phase
69
Enrollment target
20
Study locations

NCT05536973: Active Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Adverum Biotechnologies.

NCT05536973 is a Phase 2 study of Neovascular Age-related Macular Degeneration that is active but no longer recruiting, run by Adverum Biotechnologies. The registered enrollment target is 69 participants, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05536973, a Phase 2 study of Neovascular Age-related Macular Degeneration, is active but no longer recruiting, sponsored by Adverum Biotechnologies.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
69 participants
Enrollment target
20
Study locations

Study Summary

Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Primary Outcome

Incidence of ocular and non-ocular adverse events

Conditions Studied

Neovascular Age-related Macular Degeneration

Interventions

  • GENETIC ADVM-022

Study Locations (20)

California

  • Adverum Clinical Site 100 - Beverly Hills
  • Adverum Clinical Site 172 - Encino
  • Adverum Clinical Site 169 - Fullerton
  • Adverum Clinical Site 170 - Pasadena
  • Adverum Clinical Site 174 - Poway
  • Adverum Clinical Site 164 - Riverside
  • Adverum Clinical Site 166 - Sacramento
  • Adverum Clinical Site 175 - Santa Barbara

Arizona

  • Adverum Clinical Site 178 - Phoenix
  • Adverum Clinical Site 126 - Phoenix
  • Adverum Clinical Site 159 - Tucson

Florida

  • Adverum Clinical Site 124 - Deerfield Beach
  • Adverum Clinical Site 176 - Fort Lauderdale
  • Adverum Clinical Site 168 - Jacksonville

Michigan

  • Adverum Clinical Site 167 - Detroit
  • Adverum Clinical Site 161 - Royal Oak

Colorado

  • Adverum Clinical Site 116 - Lakewood

Connecticut

  • Adverum Clinical Site 165 - Waterford

Hawaii

  • Adverum Clinical Site 149 - ‘Aiea

Mississippi

  • Adverum Clinical Site 163 - Southaven

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2022-08-23
Est. Completion 2028-08
Phase Phase 2
Adverum Biotechnologies

10 total trials

What the registry record for NCT05536973 still lists

NCT05536973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which ADVM-022 is the first listed.

NCT05536973 names 20 study sites across 8 states, led by California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT05536973 about?

NCT05536973 is a clinical study titled "Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]". Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process...

What is the current status of trial NCT05536973?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2022-08-23. Estimated completion is 2028-08.

What conditions does trial NCT05536973 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.

What interventions are being tested in trial NCT05536973?

The interventions under investigation include: ADVM-022 (GENETIC).

Who is sponsoring clinical trial NCT05536973?

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

Where is trial NCT05536973 being conducted?

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

Learn More About Clinical Trials

Similar trials for Neovascular Age-related Macular Degeneration

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 NCT05536973's enrollment target sits among peer trials

69 17th of 33 higher than 17 of 33 other Neovascular Age-related Macular Degeneration trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration 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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Related registry views

Source: ClinicalTrials.gov NCT05536973, the US trial registry maintained by the National Library of Medicine. NCT05536973 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.