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Trial · NCT02482129

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Responders at Day 15Baseline (Day 1), Day 15
This analysis population includes all subjects who received any study drug, had at least 1 post-baseline efficacy assessment, had no critical protocol deviations, and had a valid determination of response status for the primary endpoint (Per Protocol Analysis Set).
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYMean Best Corrected Visual Acuity (BCVA) at Each VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29This analysis population includes all subjects who received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.lettersMEAN
PRIMARYMean Intraocular Pressure (IOP) at Each VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.mmHgMEAN
PRIMARYNumber of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Safety Analysis SetparticipantsNUMBER
PRIMARYNumber of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Safety Analysis SetparticipantsNUMBER
SECONDARYNumber of Subjects With IOP Change From Baseline to Last On-Treatment AssessmentBaseline (Day 1), Up to Day 29Safety Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMean Change From Baseline in BCVA at Each VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.lettersMEAN
SECONDARYTime-to-ResponseBaseline (Day 1), Up to Day 15Per Protocol Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYUse of Rescue TreatmentDay 4, Day 8, Day 15Per Protocol Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMean Serum Concentration of Total LME636 at Each VisitBaseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
This analysis population includes all subjects who received investigative product (IP) and had at least 1 evaluable serum sample following IP exposure.(Pharmacokinetics Analysis Set). Number Analyzed is the number of subjects with data at visit.
ng/mLMEAN
SECONDARYNumber of Subjects With Anti-LME636 Antibodies Present at Each VisitDay 1, Day 4, Day 8, Day 15, Day 22, Day 29This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).ParticipantsCOUNT_OF_PARTICIPANTS

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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