Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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).
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Retina
Enrollment Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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