Status and phase
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About
The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.
Full description
The study is an ongoing, Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:
Enrollment
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Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
689 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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