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Clinical trial

A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

ID
Name
CRTH258B2304
Description
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.
Trial arms
Trial start
2019-08-23
Estimated PCD
2023-01-31
Trial end
2023-01-31
Status
Completed
Phase
Early phase I
Treatment
Brolucizumab
5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance
Arms:
Brolucizumab 6 mg
Other names:
RTH258
Aflibercept
5 x every 4 weeks loading then every 8 weeks maintenance
Arms:
Aflibercept 2 mg
Other names:
Eylea
Size
263
Primary endpoint
Change in best-corrected visual acuity (BCVA)
Baseline to Week 52
Eligibility criteria
Inclusion Criteria: * Patients with type 1 or type 2 diabetes mellitus * Visual impairment due to Diabetic Macular Edema Exclusion Criteria: * Any active intraocular or periocular infection or active intraocular inflammation * Structural damage of the fovea * Uncontrolled glaucoma * Neovascularization of the iris Other protocol-defined inclusion/exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 263, 'type': 'ACTUAL'}}
Updated at
2023-06-13

1 organization

2 products

1 indication

Product
Brolucizumab
Indication
Diabetic Macular Edema
Product
Aflibercept
Organization
Novartis Pharmaceuticals