The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
365
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.
Time frame: At Week 12
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.
Time frame: At Week 36
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12
Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.
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Regeneron Investigational Site
Mobile, Alabama, United States
Regeneron Investigational Site 1
Phoenix, Arizona, United States
Regeneron Investigational Site 2
Phoenix, Arizona, United States
Regeneron Investigational Site 3
Phoenix, Arizona, United States
Regeneron Investigational Site 1
Tucson, Arizona, United States
Regeneron Investigational Site 2
Tucson, Arizona, United States
Regeneron Investigational Site
Arcadia, California, United States
Regeneron Investigational Site
Bakersfield, California, United States
Regeneron Investigational Site
Beverly Hills, California, United States
Regeneron Investigational Site
Encino, California, United States
...and 77 more locations
Time frame: At Week 12
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36
CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.
Time frame: At Week 36
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12
Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Time frame: At Week 12
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36
Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Time frame: At Week 36
Change From Baseline in Total Lesion Area at Week 12
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Time frame: At Week 12
Change From Baseline in Total Lesion Area at Week 36
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Time frame: At Week 36