The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy.
Group 1: Subjects will be administered intravitreal faricimab every 4 through week 48 and then will be receive faricimab every 16 weeks with an end of study visit at week 96. At any visit after Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial. Group 2: Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab every 4 weeks from week 48 to week 92 with an end of study visit at week 96. At any visit before Week 48, if rescue criteria are met, faricimab will be given every 4 weeks and the subject will continue dosing through the end of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
Faricimab is a humanized bispecific antibody binding to human Ang-2 and VEGF. For Phase III studies, the Ro 686-7461 drug product is provided in single-dose 2-mL glass vials (6 mg/0.05 mL) with L-histidine/acetate buffered solution (approximately pH 5.5) containing sodium chloride, sucrose, L-methionine, polysorbate 20, and water for injection.
California Retina Consultants
Bakersfield, California, United States
Retinal Consultants Medical Group
Modesto, California, United States
Primary Objective
Analyze 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.
Time frame: 48 weeks
Primary Objective
Analyze 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.
Time frame: 48 weeks
Change in area of RNP
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
Time frame: Baseline through week 96
Change in area of RNP within the macula
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
Time frame: Baseline through week 48 and from baseline through week 96
Change in area of RNP outside of the macula
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
Time frame: Baseline through week 48 and from baseline through week 96
Percentage of subjects with disease
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Florida Retina Institute
Orlando, Florida, United States
Retina Group of Florida
Sarasota, Florida, United States
Retina Consultants of Minnesota St. Louis Park
Saint Louis Park, Minnesota, United States
Mississippi Retina Associates
Jackson, Mississippi, United States
Long Island Vitreoretinal Consultants
Westbury, New York, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
...and 6 more locations
Percentage of subjects with neovascularization and/or vitreous hemorrhage and/or DME
Time frame: Baseline through week 96
Mean change in ETDRS
Mean change in ETDRS BCVA
Time frame: Baseline through week 48 and from baseline through week 96
Mean change in CST
Mean change in CST
Time frame: Baseline through week 48 and from baseline through week 96
Contrast Sensitivity
Contrast sensitivity as measured using the quantitative Contrast Sensitivity Function (qCSF) testing on the Manifold Contrast Vision
Time frame: Baseline through Week 48 and from baseline through week 96
Natural History of RNP
Natural history of RNP through detection of apoptosing retinal cells (DoARC) imaging
Time frame: Baseline through Week 48 and from baseline through week 96
2-step Improvement in DRSS
Proportion of subjects with at least a 2-step improvement in DRSS
Time frame: 48 weeks and 96 weeks