A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
- Conditions
- Patients With Visual Impairment Due to Diabetic Macular EdemaMacular EdemaR60.9
- Registration Number
- LBCTR2019030200
- Lead Sponsor
- ovartis Pharma Services Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4
•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
•Active proliferative diabetic retinopathy in the study eye
•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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method