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

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Diabetic Macula Edema

Treatments: Drug: Aflibercept; Drug: Brolucizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04079231

CRTH258BDE01

Details and patient eligibility

About

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).

Full description

In this 48-week, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 1:1 ratio to one of the two treatment arms and attend 14 planned visits.

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Brolucizumab 6 mg

Experimental group

Description:

Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule

Treatment:

Drug: Brolucizumab

Aflibercept 2 mg

Active Comparator group

Description:

Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks

Treatment:

Drug: Aflibercept