This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
446
Faricimab will be administered via intravitreal injection.
Change in Best Corrected Visual Acuity
Change in best corrected visual acuity (3.9 letter non-inferiority margin)
Time frame: Baseline to Week 100
Decrease in Diabetic Retinopathy Severity Score
A 2-step improvement in diabetic retinopathy severity score
Time frame: Baseline to Week 100
Decrease in Diabetic Retinopathy Severity Score
A 3-step improvement in diabetic retinopathy severity score
Time frame: Baseline to Week 100
Change in Central Subfield Thickness
Change in central subfield thickness on OCT
Time frame: Baseline to Week 100
Change in Vision Related Quality of Life
Change in vision-related quality of life (VFQ-25)
Time frame: Baseline to Week 100
Change in Letters of Vision
Gaining or losing ≥5, ≥10, or ≥15 letters of vision
Time frame: Baseline to Week 100
Absence of Diabetic Macular Edema
Absence of diabetic macular edema in the study eye
Time frame: Week 100
Absence of Intraretinal Fluid (IRF)
Absence of intraretinal fluid (IRF) in the study eye
Time frame: Week 100
Dosing Interval
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Retinal Consultants Medical Group Inc.
Modesto, California, United States
Vitreo-Retina Medical Group
Sacramento, California, United States
University Retina and Macula Associates
Oak Forest, Illinois, United States
Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center
West Monroe, Louisiana, United States
Mississippi Retina Associates
Jackson, Mississippi, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Beaumont, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Retina Consultants of Houston, dba Retina Consultants of Texas
Bellaire, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
...and 36 more locations
Dosing interval at week 100
Time frame: Week 100
Presence of Safety Outcomes
Safety outcomes (ocular and systemic AEs and SAEs)
Time frame: Baseline to Week 100