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Evaluation of Tonabersat for DME

Study acronym: AN
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study completion date: Nov 2025 to Jan 2026v13
  2. Minor Primary completion date changed from estimate of Jun 2025 to Jun 27, 2025v12
  3. Notable Primary completion date: Nov 2024 to Jun 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: May 2025 to Nov 2025
    • Site details revised at 28 of 28 sites
    v11
  4. Minor Study sites: 26 to 28v10
  5. Minor Study sites: 25 to 26v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Study sites: 24 to 25v8
  2. Minor Secondary endpoints revised (4)
    • Eligibility criteria expanded, about 2 words
    v7
  3. Minor Study sites: 15 to 24v6
  4. Minor Re-verified, no change to tracked fieldsv5
  5. Minor Study sites: 7 to 15v4
  6. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 7
    • Primary completion date: Sep 1, 2024 to Nov 2024
    • Study completion date: Mar 1, 2025 to May 2025
    • Start date changed from estimate of Mar 1, 2023 to May 2, 2023
  7. Minor Eligibility criteria shortened, about 1 word
    • Study title shortened, about 3 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
Trial Details
NCT Number NCT05727891
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation
Conditions
(from sponsor)
Diabetic Macular Edema
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov