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

• Status: Withdrawn
• Trial end date: 2023-01-31
• 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:

• Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at Screening

• BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline

• DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT

Exclusion Criteria:

• High risk or advanced proliferative diabetic retinopathy in the study eye as per reading Center

• 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 any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization

• 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