SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT03622593
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation, compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Name: Aflibercept
Description: Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).Type: Drug
C: Aflibercept Q8W
Name: Faricimab
Description: Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.Type: Drug
A: Faricimab Q8W B: Faricimab As Specified in Protocol
Name: Sham Procedure
Description: The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.Type: Drug
A: Faricimab Q8W B: Faricimab As Specified in Protocol C: Aflibercept Q8W
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
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
Measure: Change From Baseline in BCVA Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time
Time: From Baseline up to 2 years
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
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
Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time
Time: Up to 2 years
Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time: Up to 2 years
Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time
Time: Up to 2 years
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
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
Measure: Change From Baseline in Central Subfield Thickness (CST) Over Time
Time: From Baseline up to 2 years
Measure: Percentage of Participants with Absence of DME Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time
Time: Up to 2 years
Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Time: Up to 2 years
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
Measure: Percentage of Participants With Ocular Adverse Events
Time: Up to 2 years
Measure: Percentage of Participants With Non-Ocular Adverse Events
Time: Up to 2 years
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)
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)
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 2 SNPs
SNPs
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W --- --- Q16W ---
Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W --- --- Q16W ---
HPO Nodes