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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Intravitreal Injection
Intravitreal injection
Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Week 48
Mean change in BCVA from baseline to Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, Week 48
Change from baseline in BCVA averaged over a period Week 36 to Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Week 36, Week 48
Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, Week 48
Proportion of patients with a loss in BCVA of ≥15 ETDRS letters from baseline to Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, Week 48
Proportion of patients with a loss in BCVA of ≥10 ETDRS letters from baseline to Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, Week 48
Proportion of patients maintained at q12w up to Week 48
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Percentage of participants maintained at q12w (quarterly, every 12 weeks). This outcome measure is pre-specified for brolucizumab treatment arm only
Time frame: Baseline, Week 48
Proportion of patients maintained at q12w up to Week 48, within those patients that qualified for q12w at week 28
Percentage of patients maintained at (q12w) quarterly, every 12 weeks, up to Week 48, within those patients that qualified for (q12w) at week 28. This outcome measure is pre-specified for brolucizumab treatment arm only
Time frame: Week 28, Week 48
Change from baseline in central subfield thickness (CSFT, as determined by SD-OCT) at each assessment visit
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 48
Average change in CSFT from baseline over the period Week 36 through Week 48
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Week 36, Week 48
Average change in CSFT from baseline over the period Week 4 to Week 48
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Week 4, Week 48
Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 48
Change from baseline in Central Subfield Thickness-neurosensory (CSFTns, as determined by SD-OCT) at each assessment visit
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, week 48
Average change in CSFTns from baseline over the period Week 36 through Week 48
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 36, Week 48
Average change in CSFTns from baseline over the period Week 4 to Week 48
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 4, Week 48
Proportion of patients with presence of SRF, IRF and simultaneous absence of SRF and IRF at each assessment visit
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 48
Proportion of patients with presence of leakage on FA at Week 48
Assessed by fluorescein angiography
Time frame: Week 48
Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 48 (central reading)
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative
Time frame: Baseline, Week 48
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
Disease status measured by ETDRS-DRSS. Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit.
Time frame: Baseline, Week 48
Incidence of progression to PDR as assessed by ETDRS-DRSS score of at least 61 by Week 48
Incidence of progression to proliferative diabetic retinopathy (PDR) measured by ETDRS-DRSS. Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit.
Time frame: Baseline, Week 48
Rate of "inactive" PDRs by Week 48 compared to baseline
Rate of "inactive" proliferative diabetic retinopathy (PDRs) by Week 48 compared to baseline as measured by Diabetic Retinopathy Severity Scale (DRSS) score.
Time frame: Baseline, Week 48