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

• Status: Completed
• Trial end date: 2021-10-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aflibercept

Criteria

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