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

A Comparative Double Masked, Two-Arm, Randomized, Multicenter, Phase IIIb Study Analyzing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (BUZZARD)

ClinicalTrials.gov Identifier: NCT04079231

Novartis Reference Number: CRTH258BDE01

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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).

Condition 
Diabetic Macula Edema
Phase 
Phase 3
Overall status 
Not yet recruiting
Enrollment count 
356 participants
Start date 
Nov 01, 2020
Completion date 
Aug 16, 2022
Gender 
All
Age(s)
18 Years - 110 Years (Adult, Older Adult)

Interventions

Drug
Brolucizumab
Intravitreal Injection
Drug
Aflibercept
Intravitreal injection

Eligibility 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

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]