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Trial · NCT04005352

Outcomes27

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYDistribution of the Last Interval With no Disease Activity up to Week 32 - Study EyeUp to Week 32Full Analysis Set (Includes participants who were randomized and treated.)ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYAverage Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study EyeBaseline, Week 28 and Week 32Full Analysis Set - Last observation carried forward (LOCF).Scores on a scaleLEAST_SQUARES_MEAN
SECONDARYDistribution of the Last Interval With no Disease Activity up to Week 64 - Study EyeUp to Week 64Full Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDistribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study EyeUp to Week 64Full Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With no Disease Activity - Study EyeWeeks 14 and 16
Full Analysis Set. Note that the number analyzed is reduced because the Week 14 visit was conducted at the investigator's discretion, and because some patients had already stopped treatment by Week 16.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study EyeUp to Week 64Full Analysis Set - subjects with no important protocol deviations with impactweeksNUMBER
SECONDARYTime-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study EyeUp to Week 64Full Analysis Set - subjects with no important protocol deviations with impactParticipantsNUMBER
SECONDARYAverage Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study EyeBaseline, Week 60 and Week 64Full Analysis Set - LOCFScores on a scaleLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study EyeBaseline, Week 32, and Week 64Full Analysis Set - LOCFParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study EyeWeek 32 and Week 64Full Analysis Set - LOCFParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAverage Change From Baseline in Central Subfield Thickness (CSFT) - Study EyeBaseline, Weeks 28 and 32 and at Weeks 60 and 64Full Analysis Set - LOCFmicrometersLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study EyeAt Weeks 28, 32, 60 and 64Full Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study EyeAt Weeks 28, 32, 60 and 64Full Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study EyeBaseline, Week 32, and Week 64Full Analysis SetScores on a scaleLEAST_SQUARES_MEAN

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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