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A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT03481660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-01-07

Study results available
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Summary

This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).

Conditions

Interventions

DRUG

Brolucizumab

Intravitreal injection

DRUG

Aflibercept

Intravitreal injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2020-06-29
Completion
2021-06-08

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Latvia
  • Lebanon
  • Lithuania
  • Malaysia
  • Norway
  • Poland
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481660 on ClinicalTrials.gov