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Trial · NCT02647359

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent Change From Baseline in Maximum Reading Speed of Oculus Unitas (OU) (Both Eyes) at Week 48, as Measured Using the Minnesota Low Vision Reading Test (MNREAD) Acuity ChartsBaseline, Week 48
The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
percent changeLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Reading Accessibility Index of Both Eyes at Week 48Baseline, Week 48The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.units on a scaleMEAN
SECONDARYChange From Baseline in Best Corrected Visual Acuity (BCVA) at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
LogMARMEAN
SECONDARYPercent Change From Baseline in Maximum Reading Speed of Oculus Dexter (OD) (Right Eye) and Oculus Sinister (OS) (Left Eye) at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
percent changeMEAN
SECONDARYChange From Baseline in Reading Accessibility Index of Right Eye and Left Eye at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
units on a scaleMEAN
SECONDARYChange From Baseline in Critical Print Size (CPS) of Both Eyes, Right Eye, and Left Eye at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
LogMARMEAN
SECONDARYChange From Baseline in Reading Acuity (RA) of Both Eyes, Right Eye, and Left Eye at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
LogMARMEAN
SECONDARYNumber of Participants With Change From Baseline in Severity of Corneal Keratopathy at Week 48Baseline to Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Iris Area at Week 48Baseline, Week 48
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
millimeter square (mm^2)MEAN
SECONDARYChange From Baseline in BCVA at Week 240Baseline, Week 240
The ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
logMARMEAN
SECONDARYNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)Baseline up to Week 244The safety population included all randomized participants who received at least 1 dose of study drug.ParticipantsCOUNT_OF_PARTICIPANTS

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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