Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05536973 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date changed from estimate of Aug 2028 to Aug 26, 2024
    • Study completion date: Nov 2028 to Aug 2028
    • Collaborators shortened, about 1 word
    v6
  3. Primary completion date: Feb 2024 to Aug 2028v5 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 72 to confirmed 69
    • Study completion date: Feb 2024 to Nov 2028
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: 7 to 10
    • Site details revised at 39 of 39 sites
    • Study description shortened, about 2 words
  4. Study description expanded, about 7 words
    • Site details revised at 5 of 39 sites
    • Eligibility criteria expanded, about 4 words
    v4
  5. Eligibility criteria shortened, about 27 words
    • Site details revised at 2 of 39 sites
    v3
  6. Study sites: 5 to 39v2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 6 to 7
    • Study description shortened, about 1 word
    • Study title expanded, about 1 word
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05536973
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions
(from sponsor)		 Neovascular Age-related Macular Degeneration
Related terms Blindness, Choroidal Neovascularization, Eye Diseases, Macular Degeneration, Wet Macular Degeneration
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov