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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 : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Biological: Brolucizumab Biological: Aflibercept Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
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
Official Title: 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)
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : February 8, 2021
Estimated Study Completion Date : January 14, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Masked Arm 1
Brolucizumab 6 mg dosed every 4 weeks from Baseline (Week 0) through Week 100
 Biological: Brolucizumab
6 mg/0.05mL solution for intravitreal injection
Other Name: RTH258
Active Comparator: Masked Arm 2
Aflibercept 2 mg dosed every 4 weeks from Baseline (Week 0) through Week 100
 Biological: Aflibercept
2 mg/0.05mL solution for intravitreal injection
Other Name: EYLEA


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Stable VA or improvement in VA at Week 52 and Week 104 [ Time Frame: Baseline, Week 52, Week 104 ]
    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.

  2. Loss in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]
    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.

  3. Gain in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]
    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.

  4. Change in Central Subfield Thickness (CST) from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]
    CST will be assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images.

  5. Intraretinal fluid (IRF) at each post-baseline visit [ Time Frame: Up to Week 104 ]
    IRF will be assessed using SD-OCT images. The number of subjects with IRF and or SRF (present, absent) will be reported for each post-baseline visit.

  6. Subretinal fluid (SRF) at each post-baseline visit [ Time Frame: Up to Week 104 ]
    SRF will be assessed using SD-OCT images. The number of subjects with SRF and or IRF (present, absent) will be reported for each post-baseline visit.

  7. Sub-Retinal Pigment Epithelium (sub-RPE) fluid in patients with sub-RPE fluid at baseline [ Time Frame: Baseline, Up to Week 104 ]
    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.

  8. Fluid-free status (no IRF, SRF or sub-RPE fluid) at each post-baseline treatment visit [ Time Frame: Up to Week 104 ]
    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.

  9. Time to first dry retina (no IRF or SRF) finding [ Time Frame: Time to event (Baseline, Up to Week 104) ]
    IRF and SRF will be assessed using SD-OCT images. A dry retina is defined as no IRF or SRF at the visit.

  10. Time to first sustained dry retina (no IRF or SRF at ≥ 2 consecutive visits) finding [ Time Frame: Time to event (Baseline, Up to Week 104) ]
    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.

  11. Change in anti-drug antibody (ADA) levels from baseline [ Time Frame: Baseline, Up to Week 104 ]
    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.

  12. Change in systemic brolucizumab levels from baseline [ Time Frame: Baseline, Up to Week 104 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Contacts and Locations
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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): NCT03710564


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03710564    
Other Study ID Numbers: CRTH258AUS04
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
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 www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
neovascular age-related macular degeneration
nAMD
intravitreal injection
IVT
anti-VEGF
brolucizumab
 aflibercept
EYLEA
double-masked
MERLIN
BEOVU
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases