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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 )

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 : June 9, 2020
Estimated Study Completion Date : September 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Masked Arm 1
Brolucizumab 6 mg dosed every 4 weeks from Baseline (Week 0) through Week 48
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 48
Biological: Aflibercept
2 mg/0.05mL solution for intravitreal injection
Other Name: EYLEA




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 [ 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  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 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.

  11. 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.

  12. 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.



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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
  • 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


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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

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Locations
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United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85016
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85020
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85053
United States, California
Novartis Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Novartis Investigative Site Recruiting
Huntington Beach, California, United States, 92647
Novartis Investigative Site Recruiting
Mountain View, California, United States, 94040
Novartis Investigative Site Recruiting
Oakland, California, United States, 94609
Novartis Investigative Site Recruiting
Oxnard, California, United States, 93036
Novartis Investigative Site Recruiting
Palo Alto, California, United States, 94303
Novartis Investigative Site Recruiting
Redlands, California, United States, 92374
Novartis Investigative Site Recruiting
Sacramento, California, United States, 95841
Novartis Investigative Site Recruiting
San Francisco, California, United States, 94107
Novartis Investigative Site Recruiting
Santa Barbara, California, United States, 93103
United States, Colorado
Novartis Investigative Site Recruiting
Colorado Springs, Colorado, United States, 80909
Novartis Investigative Site Recruiting
Golden, Colorado, United States, 80401
United States, Florida
Novartis Investigative Site Recruiting
Deerfield Beach, Florida, United States, 33064
Novartis Investigative Site Recruiting
Fort Lauderdale, Florida, United States, 33308
Novartis Investigative Site Recruiting
Fort Myers, Florida, United States, 33912-7125
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33126
Novartis Investigative Site Recruiting
Mount Dora, Florida, United States, 32757
Novartis Investigative Site Withdrawn
Ocala, Florida, United States, 34474
Novartis Investigative Site Recruiting
Pensacola, Florida, United States, 32503
Novartis Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33711
Novartis Investigative Site Recruiting
Stuart, Florida, United States, 34994
United States, Georgia
Novartis Investigative Site Recruiting
Marietta, Georgia, United States, 30060
United States, Hawaii
Novartis Investigative Site Recruiting
'Aiea, Hawaii, United States, 96701
United States, Illinois
Novartis Investigative Site Recruiting
Wheaton, Illinois, United States, 60187
United States, Iowa
Novartis Investigative Site Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Novartis Investigative Site Recruiting
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Novartis Investigative Site Recruiting
Paducah, Kentucky, United States, 42001
United States, Louisiana
Novartis Investigative Site Recruiting
New Orleans, Louisiana, United States, 70115-8139
Novartis Investigative Site Recruiting
West Monroe, Louisiana, United States, 71291
United States, Maryland
Novartis Investigative Site Recruiting
Waldorf, Maryland, United States, 20602
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02111
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
Novartis Investigative Site Recruiting
Springfield, Massachusetts, United States, 01107
United States, Michigan
Novartis Investigative Site Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Novartis Investigative Site Recruiting
Las Vegas, Nevada, United States, 89144
Novartis Investigative Site Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Novartis Investigative Site Recruiting
Bloomfield, New Jersey, United States, 07003
Novartis Investigative Site Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Novartis Investigative Site Recruiting
Syracuse, New York, United States, 13224
United States, North Carolina
Novartis Investigative Site Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Novartis Investigative Site Recruiting
Cleveland, Ohio, United States, 44122
Novartis Investigative Site Recruiting
Fairfield, Ohio, United States, 45014
United States, Oregon
Novartis Investigative Site Recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Novartis Investigative Site Recruiting
Kingston, Pennsylvania, United States, 95403
United States, Tennessee
Novartis Investigative Site Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Novartis Investigative Site Recruiting
Abilene, Texas, United States, 79606
Novartis Investigative Site Recruiting
Austin, Texas, United States, 78705
Novartis Investigative Site Recruiting
Austin, Texas, United States, 78731
Novartis Investigative Site Recruiting
Austin, Texas, United States, 78793
Novartis Investigative Site Recruiting
Fort Worth, Texas, United States, 76102
Novartis Investigative Site Recruiting
Fort Worth, Texas, United States, 76104
Novartis Investigative Site Recruiting
Harlingen, Texas, United States, 78550
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78215
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78240
United States, Virginia
Novartis Investigative Site Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Novartis Investigative Site Recruiting
Spokane, Washington, United States, 99204
Puerto Rico
Novartis Investigative Site Recruiting
Arecibo, Puerto Rico, 00612
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03710564     History of Changes
Other Study ID Numbers: CRTH258AUS04
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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 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

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases