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Trial · NCT06453694

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryVisual fields6 months
Difference in change in Humphrey Visual fields score from baseline to each assessment time point between groups. Data derived from automated perimetry are continuous and expressed in decibels. The mean deviation calculated from a Humphrey Visual Field analyzer (24-2 fast paradigm) represents the difference between an individual's test performance and the performance of a normally-sighted control of the same age.
SecondaryVision Related Quality of Life6 monthsNational Eye Institute Visual Functioning Questionnaire (VFQ-25) scores at baseline, 1 month, 3 months, and 6 months in each arm. Scores range from 0 = worst to 100 = best
SecondaryEfgartigimod safety measures6 monthsFrequency and type of overall adverse events, treatment-related adverse events, and serious adverse events
OtherNumber and proportion of patients enrolled within 3, 5, 7, and 10 days of visual symptom onsetDay 0Number and proportion of patients enrolled within 3, 5, 7, and 10 days of visual symptom onset
OtherContrast enhancementDay 0Number and proportion of patients enrolled with contrast enhancement of the optic nerves on MRI
OtherMedian duration (in days) from onset of blurry vision or visual acuity change to randomizationDay 0Median duration (in days) from onset of blurry vision or visual acuity change to randomization
OtherMedian duration (in days) from onset of eye pain or headache to randomizationDay 0Median duration (in days) from onset of eye pain or headache to randomization
OtherNumber and proportion of overall participants with each diagnosisDay 30Number and proportion of overall participants with a final diagnosis of AQP4+ NMOSD, seronegative NMOSD, MOGAD, MS-related optic neuritis, idiopathic acute optic neuritis, or other diagnosis
OtherProportion amongst screened and recruited participants with HCVA of each visual acuity severityDay 0Proportion amongst screened and recruited participants with HCVA worse than logMAR 0.48 (20/60), logMAR 0.7 (20/100), and logMAR 1 (20/200)
OtherRetinal nerve fiber layer (RNFL) thickness at 1 month between groups1 monthRetinal nerve fiber layer (RNFL) thickness at 1 month between groups
OtherRetinal nerve fiber layer (RNFL) thickness at 3 months between groups3 monthsRetinal nerve fiber layer (RNFL) thickness at 3 months between groups
OtherRetinal nerve fiber layer (RNFL) thickness at 6 months between groups6 monthsRetinal nerve fiber layer (RNFL) thickness at 6 months between groups
OtherGanglion cell layer (GCL) thickness at 1 month between groups1 monthGanglion cell layer (GCL) thickness at 1 month between groups
OtherGanglion cell layer (GCL) thickness at 3 months between groups3 monthsGanglion cell layer (GCL) thickness at 3 months between groups
OtherGanglion cell layer (GCL) thickness at 6 months between groups6 monthsGanglion cell layer (GCL) thickness at 6 months between groups

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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