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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

StatusEnrolling by Invitation
PhasePhase 2
SponsorAbbVie
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 3 months later Mar 2028 → Jul 2031
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from AbbVie

Record History

  1. Primary and study completion pushed from Mar 2028 to Jul 2031 Primary endpoint(s) modified · Phase changed: not specified → Phase 2 · Trial arms changed: 1 → 2 · 5 morev6 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: not specified → Phase 2
    • Trial arms changed: 1 → 2
    • Enrollment target: 115 to 116
    • Interventions: No intervention. (Other) to Ranibizumab (Drug), Standard of Care (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 9
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Jun 17, 2024, no change to tracked fieldsv4-v5
  3. Lead sponsor: REGENXBIO Inc. to AbbVie Collaborators shortened, about 1 wordv3 Show 1 more changeShow less
    • Collaborators shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 26, 2026 to Mar 2028 Enrollment target: 95 to 115 · Study sites: 15 to 16 · Completion date: May 7, 2027 to Mar 2028 · 1 morev2 Show 4 more changesShow less
    • Enrollment target: 95 to 115
    • Study sites: 15 to 16
    • Completion date: May 7, 2027 to Mar 2028
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
Trial Details
NCT Number NCT05210803
Lead Sponsor AbbVie
Collaborators: REGENXBIO Inc.
Conditions Neovascular Age-Related Macular Degeneration (nAMD)
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov