Primary Outcomes

Measure: Percentage of Participants with Adverse Events

Time: Up to approximately 6 years

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Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety.

Measure: Change From Baseline in Behavioral Findings, as Assessed by the Columbia-Suicide

Time: Baseline, Every 8 Weeks or Every 16 Weeks, and End of Treatment (up to approximately 6 years)

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Description: MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment.

Measure: Change From Baseline in Cognition, using Montreal Cognitive Assessment (MoCA)

Time: Baseline, Every 16 Weeks, End of Treatment (up to approximately 6 years)

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Primary Outcomes

Description: BCVA is measured using ETDRS visual acuity charts.

Measure: Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.

Time: Year 1

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Secondary Outcomes

Measure: Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.

Time: Year 1

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Measure: Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1.

Time: Year 1

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Measure: Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1.

Time: Year 1

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Measure: Proportion of subjects with BCVA Snellen equivalent of 20/40 or better.

Time: Year 1

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Measure: Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse.

Time: Year 1

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Measure: Mean change in OCT central subfield retinal thickness (CST) from Day 1.

Time: Year 1

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Measure: Mean change in OCT intraretinal fluid volume from Day 1.

Time: Year 1

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Measure: Mean change in OCT subretinal fluid volume from Day 1.

Time: Year 1

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Measure: Proportion of subjects without intraretinal fluid on OCT.

Time: Year 1

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Measure: Proportion of subjects without subretinal fluid on OCT.

Time: Year 1

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Measure: Mean change in CNV total lesion area on FA from baseline.

Time: Year 1

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Measure: Mean chance in area of leakage on FA from baseline.

Time: Year 1

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Primary Outcomes

Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.

Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year

Time: Baseline (Day 1) and 1 year

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Secondary Outcomes

Measure: Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year

Time: Baseline and 1 year

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Measure: Change From Baseline in BCVA Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time

Time: Up to 2 years

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Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year

Time: 1 year

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Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years

Time: 2 years

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Measure: Change From Baseline in Central Subfield Thickness Over Time

Time: From Baseline up to 2 years

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Measure: Change From Baseline in Central Subfield Thickness at 1 Year

Time: Baseline and 1 year

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Measure: Percentage of Participants with Absence of DME Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time

Time: Up to 2 years

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Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants with At Least One Ocular Adverse Event

Time: Up to 2 years

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Measure: Percentage of Participants with At Least One Non-Ocular Adverse Event

Time: Up to 2 years

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Measure: Plasma Concentration of Faricimab Over Time

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

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Measure: Percentage of Participants with Presence of Anti-Drug Antibodies

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

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Primary Outcomes

Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.

Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year

Time: Baseline (Day 1) and 1 year

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Secondary Outcomes

Measure: Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year

Time: Baseline and 1 year

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Measure: Change From Baseline in BCVA Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time

Time: Up to 2 years

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Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year

Time: 1 year

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Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years

Time: 2 years

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Measure: Change From Baseline in Central Subfield Thickness Over Time

Time: From Baseline up to 2 years

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Measure: Change From Baseline in Central Subfield Thickness at 1 Year

Time: Baseline and 1 year

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Measure: Percentage of Participants with Absence of DME Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time

Time: Up to 2 years

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Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time

Time: Up to 2 years

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Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time

Time: From Baseline up to 2 years

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Measure: Percentage of Participants with At Least One Ocular Adverse Event

Time: Up to 2 years

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Measure: Percentage of Participants with At Least One Non-Ocular Adverse Event

Time: Up to 2 years

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Measure: Plasma Concentration of Faricimab Over Time

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

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Measure: Percentage of Participants with Presence of Anti-Drug Antibodies

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

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