Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)

Study Identifier
M24-528
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-512298-28-00
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Study Details

Medical Condition
  • Macular Degeneration - Other
  • Study Drug
  • Surabgene Lomparvovec (ABBV-RGX-314)
  • Ranibizumab Control
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    50+ years

    Protocol Summary

    Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).

    Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.

    Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Barnet Dulaney Perkins Eye Centers /ID# 279265
    Mesa, Arizona, United States, 85206
    Status
    Recruiting
    Location
    American Vision Partners /ID# 264615
    Sun City, Arizona, United States, 85351
    Status
    Recruiting
    Location
    Retinal Diagnostic Center /ID# 263054
    Campbell, California, United States, 95008
    Status
    Recruiting
    Location
    The Retina Partners /ID# 263265
    Encino, California, United States, 91436
    Status
    Recruiting
    Location
    Retina Associates of Southern California /ID# 263056
    Huntington Beach, California, United States, 92647
    Status
    Recruiting
    Location
    Northern California Retina Vitreous Associates - Mountain View /ID# 263990
    Mountain View, California, United States, 94040-4119
    Status
    Recruiting
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