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Trial · NCT02259088

Outcomes21

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12Baseline, Monthly from Month 1 through Month 12Full Analysis Set (FAS). Missing values imputed by the mean value last observation carried forward (MV-LOCF).lettersMEAN
SECONDARYMean Change From Baseline in BCVA (Letters) at Each VisitBaseline, Monthly from Month 1 through Month 12
Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
lettersMEAN
SECONDARYMean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each VisitBaseline, Monthly from Month 1 through Month 12
Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
micrometersMEAN
SECONDARYPercentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12Baseline, Month 12Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).percentage of participantsNUMBER
SECONDARYPercentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12Baseline, Month 12Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).percentage of participantsNUMBER
SECONDARYPercentage of Patients With BCVA ≥ 73 Letters at Month 12Month 12Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).percentage of participantsNUMBER
SECONDARYMean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3Monthly from Month 3 through Month 12Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).lettersMEAN
SECONDARYMean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite ScoreBaseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN
SECONDARYMean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12Baseline, Month 6, Month 12Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.units on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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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