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

In this 2-year, randomized, double-masked, multicenter, active controlled study, consenting
patients will be randomized in a 1:1:1 ratio to one of the three treatment arms (Brolucizumab
3 mg, Brolucizumab 6 mg, or Aflibercept 2 mg) and attend 28 planned visits.

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