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This study was cancelled due to COVID-19.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6 mg | Experimental | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
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| Aflibercept 2 mg | Active Comparator | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Drug | Intravitreal Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 36, Week 48 |
| Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com.
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| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
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| Aflibercept | Drug | Intravitreal injection |
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BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts |
| 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 | 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 | Baseline, Week 48 |
| Proportion of patients maintained at q12w up to Week 48 | Percentage of participants maintained at q12w (quarterly, every 12 weeks). This outcome measure is pre-specified for brolucizumab treatment arm only | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Baseline, Week 48 |
| Proportion of patients with presence of leakage on FA at Week 48 | Assessed by fluorescein angiography | 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 | 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. | 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. | 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. | Baseline, Week 48 |