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

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ClinicalTrials.gov Identifier: NCT04079231
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease Intervention/treatment Phase
Diabetic Macula Edema Drug: Brolucizumab Drug: Aflibercept Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
Drug: Brolucizumab
Intravitreal Injection
Other Name: RTH258, ESBA1008

Active Comparator: Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Drug: Aflibercept
Intravitreal injection
Other Name: Eylea




Primary Outcome Measures :
  1. Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48 [ Time Frame: Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  2. Mean change in BCVA from baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts


Secondary Outcome Measures :
  1. Change from baseline in BCVA averaged over a period Week 36 to Week 48 [ Time Frame: Week 36, Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  2. Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  3. Proportion of patients with a loss in BCVA of ≥15 ETDRS letters from baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  4. Proportion of patients with a loss in BCVA of ≥10 ETDRS letters from baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  5. Proportion of patients maintained at q12w up to Week 48 [ Time Frame: Baseline, Week 48 ]
    Percentage of participants maintained at q12w (quarterly, every 12 weeks). This outcome measure is pre-specified for brolucizumab treatment arm only

  6. Proportion of patients maintained at q12w up to Week 48, within those patients that qualified for q12w at week 28 [ Time Frame: Week 28, Week 48 ]
    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

  7. Change from baseline in central subfield thickness (CSFT, as determined by SD-OCT) at each assessment visit [ Time Frame: Baseline, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  8. Average change in CSFT from baseline over the period Week 36 through Week 48 [ Time Frame: Week 36, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  9. Average change in CSFT from baseline over the period Week 4 to Week 48 [ Time Frame: Week 4, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  10. Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit [ Time Frame: Baseline, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  11. Change from baseline in Central Subfield Thickness-neurosensory (CSFTns, as determined by SD-OCT) at each assessment visit [ Time Frame: Baseline, week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  12. Average change in CSFTns from baseline over the period Week 36 through Week 48 [ Time Frame: Baseline, Week 36, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  13. Average change in CSFTns from baseline over the period Week 4 to Week 48 [ Time Frame: Baseline, Week 4, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  14. Proportion of patients with presence of SRF, IRF and simultaneous absence of SRF and IRF at each assessment visit [ Time Frame: Baseline, Week 48 ]
    Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  15. Proportion of patients with presence of leakage on FA at Week 48 [ Time Frame: Week 48 ]
    Assessed by fluorescein angiography

  16. Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 48 (central reading) [ Time Frame: Baseline, Week 48 ]
    The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative

  17. 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 [ Time Frame: Baseline, Week 48 ]
    Disease status measured by ETDRS-DRSS. Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit.

  18. Incidence of progression to PDR as assessed by ETDRS-DRSS score of at least 61 by Week 48 [ Time Frame: Baseline, Week 48 ]
    Incidence of progression to proliferative diabetic retinopathy (PDR) measured by ETDRS-DRSS. Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit.

  19. Rate of "inactive" PDRs by Week 48 compared to baseline [ Time Frame: Baseline, Week 48 ]
    Rate of "inactive" proliferative diabetic retinopathy (PDRs) by Week 48 compared to baseline as measured by Diabetic Retinopathy Severity Scale (DRSS) score.



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079231


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04079231     History of Changes
Other Study ID Numbers: CRTH258BDE01
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetic Macula Edema
Intravitreal injection
brolucizumab
aflibercept
double-masked
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases