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Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)

Study acronym: NOVA-1
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: May 2027 to Apr 2027
    • Study completion date: Oct 2027 to Sep 2027
    v22
  2. Primary completion moved earlier from Oct 2027 to May 2027v21
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 139
    • Site details revised at 42 of 42 sites
    v20
  4. Primary and study completion dates: Sep 2027 to Oct 2027v19
  5. Study sites: 41 to 42
    • Eligibility criteria shortened, about 4 words
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 44 to 41v17
  2. Study sites: 30 to 44v16
  3. Interventions: AR-14034 SR implant higher dose (Drug), AR-14034 SR implant lower dose (Drug), Aflibercept Injection (Drug), Sham procedure (Drug) to AR-14034 SR implant (Drug), AR-14034 SR implant higher dose (Drug), AR-14034 SR implant lower dose (Drug), Aflibercept Injection (Drug)…
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 7 words
    v15
  4. Primary and study completion dates: Apr 2027 to Sep 2027v14
  5. Study sites: 6 to 30
    • Primary and study completion dates: Mar 2027 to Apr 2027
    v13
  6. Study Identification, Study Status, Oversightv12
  7. Lead sponsor: Aerie Pharmaceuticals to Alcon Research
    • Collaborators shortened, about 2 words
    v11
  8. Primary and study completion dates: Feb 2027 to Mar 2027v10
  9. Primary and study completion dates: Oct 2025 to Feb 2027v9
  10. Primary and study completion dates: May 2025 to Oct 2025v8
  11. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 2025 to May 2025
    • Start date changed from estimate of Dec 2023 to Dec 6, 2023
    • Site details revised at 6 of 6 sites
    v7
  12. Primary and study completion dates: Jan 2027 to Apr 2025
    • Study sites: 0 to 6
    • Start date: Nov 2023 to Dec 2023
    v6
  13. Primary endpoint revised
    • Primary and study completion dates: Oct 2026 to Jan 2027
    v5
  14. Start date: Aug 2023 to Nov 2023v4
  15. Start date: Jul 2023 to Aug 2023v3
  16. Primary and study completion dates: Nov 2026 to Oct 2026
    • Start date: Jun 2023 to Jul 2023
    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.
Alcon Research
30 trials monitored
See 3 trials at risk
The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).
Trial Details
NCT Number NCT05769153
Lead Sponsor Alcon Research
Conditions
(from sponsor)		 Neovascular Age-related Macular Degeneration (nAMD)
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov