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Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections (MERLIN)

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ClinicalTrials.gov Identifier: NCT03710564
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
Change from baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 [ Time Frame: Baseline (Week 0), Week 52 ]
BCVA will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Baseline BCVA is defined as the last measurement on or prior to the baseline visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03710564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Stable VA or improvement in VA at Week 52 [ Time Frame: Baseline, Week 52 ]
    BCVA will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with no change or gain in BCVA compared to baseline will be reported.
  • Loss in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 52 ]
    BCVA will be assessed using the ETDRS visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with loss in BCVA of 5/10/15 letters or more from baseline will be reported for each post-baseline visit.
  • Gain in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 52 ]
    BCVA will be assessed using the ETDRS visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with gain in BCVA of 5/10/15 letters or more from baseline will be reported for each post-baseline visit.
  • Change in Central Subfield Thickness (CST) from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 52 ]
    CST will be assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images.
  • Intraretinal fluid (IRF) at each post-baseline visit [ Time Frame: Up to Week 52 ]
    IRF will be assessed using SD-OCT images. The number of subjects with IRF (present, absent) will be reported for each post-baseline visit.
  • Subretinal fluid (SRF) at each post-baseline visit [ Time Frame: Up to Week 52 ]
    SRF will be assessed using SD-OCT images. The number of subjects with SRF (present, absent) will be reported for each post-baseline visit.
  • Sub-Retinal Pigment Epithelium (sub-RPE) fluid in patients with sub-RPE fluid at baseline [ Time Frame: Baseline, Up to Week 52 ]
    Sub-RPE fluid will be assessed using SD-OCT images. The number of subjects with sub-RPE fluid in subjects with sub-RPE fluid at baseline (present, absent) will be reported for each post-baseline visit.
  • Fluid-free status (no IRF, SRF or sub-RPE fluid) at each post-baseline treatment visit [ Time Frame: Up to Week 52 ]
    IRF, SRF, and sub-RPE fluid will assessed using SD-OCT images. The number of subjects with fluid-free status (no IRF, SRF, or sub-RPE) will be reported for each post-baseline visit.
  • Time to first dry retina (no IRF or SRF) finding [ Time Frame: Time to event (Baseline, Up to Week 52) ]
    IRF and SRF will be assessed using SD-OCT images. A dry retina is defined as no IRF or SRF at the visit.
  • Time to first sustained dry retina (no IRF or SRF at ≥ 2 consecutive visits) finding [ Time Frame: Time to event (Baseline, Up to Week 52) ]
    IRF and SRF will be assessed using SD-OCT images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits.
  • Change in anti-drug antibody (ADA) levels from baseline [ Time Frame: Baseline, Up to Week 52 ]
    A blood sample will be collected. The baseline sample will be collected prior to first dose of study treatment. This outcome measure is pre-specified for the brolucizumab arm only.
  • Change in systemic brolucizumab levels from baseline [ Time Frame: Baseline, Up to Week 52 ]
    A blood sample will be collected. The baseline sample will be collected prior to first dose of study treatment. This outcome measure is pre-specified for the brolucizumab arm only.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
Official Title  ICMJE A Multicenter, Randomized, Double-masked Phase 3a Study to Assess Safety and Efficacy of Brolucizumab 6 mg q4 Weeks Compared to Aflibercept 2 mg q4 Weeks in Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN)
Brief Summary The purpose of this study is to compare safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those nAMD patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
multicenter, randomized, double-masked
Masking: Double (Participant, Investigator)
Masking Description:
Additionally, the care provider will be masked.
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Biological: Brolucizumab
    6 mg/0.05mL solution for intravitreal injection
    Other Name: RTH258
  • Biological: Aflibercept
    2 mg/0.05mL solution for intravitreal injection
    Other Name: EYLEA
Study Arms  ICMJE
  • Experimental: Masked Arm 1
    Brolucizumab 6 mg dosed every 4 weeks from Baseline (Week 0) through Week 48
    Intervention: Biological: Brolucizumab
  • Active Comparator: Masked Arm 2
    Aflibercept 2 mg dosed every 4 weeks from Baseline (Week 0) through Week 48
    Intervention: Biological: Aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 29, 2020
Estimated Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sign informed consent
  • Diagnosis of wet age-related macular degeneration (AMD)
  • Currently receiving anti-VEGF injections

Exclusion Criteria:

  • Active infection or inflammation in either eye
  • Significant fibrosis in the study eye
  • Recent ocular surgery
  • Uncontrolled glaucoma
  • Previous treatment with brolucizumab in the study eye
  • Use of medications as specified in the protocol
  • Pregnant, nursing
  • Of child-bearing potential unless using highly effective method of contraception

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE United States,   Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03710564
Other Study ID Numbers  ICMJE CRTH258AUS04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 www.clinicalstudydatarequest.com
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP