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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

Study acronym: ASCENT
StatusActive, Not Recruiting
PhasePhase 3
SponsorAbbVie
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 714 to confirmed 735 · Site details revised at 181 of 181 sitesv10 Show 2 more changesShow less
    • Enrollment target: estimated 714 to confirmed 735
    • Site details revised at 181 of 181 sites
  2. Enrollment target: 660 to 714 Eligibility criteria shortened, about 26 words · Secondary endpoints: 34 to 35 · Study description revised · 1 morev9 Show 4 more changesShow less
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints: 34 to 35
    • Study description revised
    • Study sites revised (181)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 11 of 181 sitesv8
  4. Primary completion date: Nov 2025 to Oct 2026 Primary endpoints: 1 to 2 · Study sites: 128 to 181 · Completion date: Nov 2026 to Nov 2027 · 3 morev7 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 128 to 181
    • Completion date: Nov 2026 to Nov 2027
    • Eligibility criteria expanded, about 226 words
    • Secondary endpoints: 27 to 34
    • Study description expanded, about 152 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Dec 28, 2021 to Jan 13, 2022 Site details revised at 11 of 128 sitesv6 Show 1 more changeShow less
    • Site details revised at 11 of 128 sites
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Feb 2025 to Nov 2025 Enrollment target: 465 to 660 · Study sites: 94 to 128 · Completion date: Dec 2025 to Nov 2026 · 5 morev5 Show 8 more changesShow less
    • Enrollment target: 465 to 660
    • Study sites: 94 to 128
    • Completion date: Dec 2025 to Nov 2026
    • Interventions: Aflibercept (EYLEA®) (Biological), RGX-314 Dose 1 (Genetic), RGX-314 Dose 2 (Genetic) to ABBV-RGX-314 Dose 1 (Genetic), ABBV-RGX-314 Dose 2 (Genetic), Aflibercept (EYLEA®) (Biological)
    • Secondary endpoints: 6 to 27
    • Study description revised
    • Eligibility criteria expanded, about 4 words
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 93 to 94v4
  3. Study sites: 88 to 93v3
  4. Lead sponsor: REGENXBIO Inc. to AbbVie Primary completion date: Apr 2024 to Feb 2025 · Study sites: 17 to 88 · Completion date: Dec 2024 to Dec 2025 · 2 morev2 Show 5 more changesShow less
    • Primary completion date: Apr 2024 to Feb 2025
    • Study sites: 17 to 88
    • Completion date: Dec 2024 to Dec 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 6 entries

    See this version in full on ClinicalTrials.gov ↗

  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.
AbbVie
345 trials monitored
See 27 trials at risk
ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
Trial Details
NCT Number NCT05407636
Lead Sponsor AbbVie
Collaborators: REGENXBIO Inc.
Conditions AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, WetAMD, CNV
Enrollment 735 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov