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

Study acronym: ARTEMIS
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv11 Show 4 more changesShow less
    • Enrollment target: estimated 284 to confirmed 311
    • Study sites: 79 to 75
    • Secondary endpoints: 25 to 27
    • Study description expanded, about 16 words
  2. Primary endpoint revisedv10 Show 5 more changesShow less
    • Primary completion date: Apr 28, 2027 to Dec 22, 2026
    • Study completion date: Mar 25, 2030 to Nov 23, 2030
    • Eligibility criteria expanded, about 94 words
    • Secondary endpoints revised (25)
    • Study description expanded, about 21 words
  3. Study sites: 74 to 79v9
  4. Study sites: 69 to 74v8
  5. Primary completion date: Mar 25, 2030 to Apr 28, 2027
    • Study sites: 60 to 69
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 52 to 60v6
  2. Study sites: 32 to 52v5
  3. Study sites: 16 to 32v4
  4. Study sites: 6 to 16
    • Secondary endpoints: details revised at 1 of 25 entries
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT06856577
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions
(from sponsor)		 Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
Related terms Blindness, Eye Diseases
Enrollment 311 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov