Clinical trial NCT04079231: Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetic Macula Edema
Keywords: Diabetic Macula Edema
Intravitreal injection
brolucizumab
aflibercept
double-masked
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48
timeFrame: Week 48
measure: Mean change in BCVA from baseline to Week 48
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change from baseline in BCVA averaged over a period Week 36 to Week 48
timeFrame: Week 36, Week 48
measure: Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48
timeFrame: Baseline, Week 48
measure: Proportion of patients with a loss in BCVA of ≥15 ETDRS letters from baseline to Week 48
timeFrame: Baseline, Week 48
measure: Proportion of patients with a loss in BCVA of ≥10 ETDRS letters from baseline to Week 48
timeFrame: Baseline, Week 48
measure: Proportion of patients maintained at q12w up to Week 48
timeFrame: Baseline, Week 48
measure: Proportion of patients maintained at q12w up to Week 48, within those patients that qualified for q12w at week 28
timeFrame: Week 28, Week 48
measure: Change from baseline in central subfield thickness (CSFT, as determined by SD-OCT) at each assessment visit
timeFrame: Baseline, Week 48
measure: Average change in CSFT from baseline over the period Week 36 through Week 48
timeFrame: Week 36, Week 48
measure: Average change in CSFT from baseline over the period Week 4 to Week 48
timeFrame: Week 4, Week 48
measure: Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit
timeFrame: Baseline, Week 48
measure: Change from baseline in Central Subfield Thickness-neurosensory (CSFTns, as determined by SD-OCT) at each assessment visit
timeFrame: Baseline, week 48
measure: Average change in CSFTns from baseline over the period Week 36 through Week 48
timeFrame: Baseline, Week 36, Week 48
measure: Average change in CSFTns from baseline over the period Week 4 to Week 48
timeFrame: Baseline, Week 4, Week 48
measure: Proportion of patients with presence of SRF, IRF and simultaneous absence of SRF and IRF at each assessment visit
timeFrame: Baseline, Week 48
measure: Proportion of patients with presence of leakage on FA at Week 48
timeFrame: Week 48
measure: Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 48 (central reading)
timeFrame: Baseline, Week 48
measure: Patient status regarding a ≥2- and ≥3-step improvement or worsening from baseline in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit
timeFrame: Baseline, Week 48
measure: Incidence of progression to PDR as assessed by ETDRS-DRSS score of at least 61 by Week 48
timeFrame: Baseline, Week 48
measure: Rate of "inactive" PDRs by Week 48 compared to baseline
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
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