Status:
COMPLETED
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Detailed Description
This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active cont...
Eligibility Criteria
Inclusion
- Written informed consent before any assessment
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
- Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion
- Active proliferative diabetic retinopathy in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in study eye
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
- Other protocol-specified inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT03481634
Start Date
July 23 2018
End Date
October 18 2021
Last Update
January 30 2023
Active Locations (116)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85053
2
Novartis Investigative Site
Beverly Hills, California, United States, 90211
3
Novartis Investigative Site
La Jolla, California, United States, 92093
4
Novartis Investigative Site
Mountain View, California, United States, 94040