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Trial · NCT05681884

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPrimary Objective48 weeksAnalyze the change in the area of retinal non-perfusion (RNP) within the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.
PrimaryPrimary Objective48 weeksAnalyze the change in the area of retinal non-perfusion (RNP) outside the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.
SecondaryChange in area of RNPBaseline through week 96
Change in area of RNP, as assessed by a central reading center; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS
SecondaryChange in area of RNP within the maculaBaseline through week 48 and from baseline through week 96
Change in area of RNP within the macula, as assessed by ultrawide-field fluorescein; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS
SecondaryChange in area of RNP outside of the maculaBaseline through week 48 and from baseline through week 96
Change in area of RNP outside of the macula, as assessed by ultrawide-field fluorescein from baseline to week 96; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS
SecondaryPercentage of subjects with diseaseBaseline through week 96Percentage of subjects with neovascularization and/or vitreous hemorrhage and/or DME
SecondaryMean change in ETDRSBaseline through week 48 and from baseline through week 96Mean change in ETDRS BCVA
SecondaryMean change in CSTBaseline through week 48 and from baseline through week 96Mean change in CST
SecondaryContrast SensitivityBaseline through Week 48 and from baseline through week 96Contrast sensitivity as measured using the quantitative Contrast Sensitivity Function (qCSF) testing on the Manifold Contrast Vision
SecondaryNatural History of RNPBaseline through Week 48 and from baseline through week 96Natural history of RNP through detection of apoptosing retinal cells (DoARC) imaging
Secondary2-step Improvement in DRSS48 weeks and 96 weeksProportion of subjects with at least a 2-step improvement in DRSS

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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