This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
255
Intravitreal injection
The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Time frame: Day 1 to Week 48
Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy
Sight-threatening complications include diabetic macular edema, new or worsening proliferative diabetic retinopathy, and anterior segment neovascularization
Time frame: Day 1 to Week 48
Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Time frame: Day 1 to Week 48
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