Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
NCT ID: NCT04079231
Last Updated: 2021-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2021-02-01
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
Brolucizumab
Intravitreal Injection
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Aflibercept
Intravitreal injection
Interventions
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Brolucizumab
Intravitreal Injection
Aflibercept
Intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline
* DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT
Exclusion Criteria
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
* Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization
* Stroke or myocardial infarction during the 6-month period prior to baseline
18 Years
110 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Other Identifiers
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CRTH258BDE01
Identifier Type: -
Identifier Source: org_study_id
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