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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03823300




Registration number
NCT03823300
Ethics application status
Date submitted
29/01/2019
Date registered
30/01/2019
Date last updated
13/01/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)
Secondary ID [1] 0 0
2018-004042-42
Secondary ID [2] 0 0
GR40844
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Treatment: Drugs - Aflibercept
Treatment: Surgery - Sham Procedure

Experimental: Arm A: Faricimab -

Active comparator: Arm B: Aflibercept -


Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

Treatment: Drugs: Aflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).

Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [1] 0 0
From Baseline through Week 48
Secondary outcome [1] 0 0
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Timepoint [1] 0 0
From Baseline through Week 60
Secondary outcome [2] 0 0
Change From Baseline in BCVA in the Study Eye Over Time
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [3] 0 0
Percentage of Participants Gaining Greater Than or Equal to (=)15, =10, =5, or =0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [3] 0 0
Baseline, average of Weeks 40, 44, and 48
Secondary outcome [4] 0 0
Percentage of Participants Gaining =15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Timepoint [4] 0 0
Baseline, average of Weeks 52, 56, and 60
Secondary outcome [5] 0 0
Percentage of Participants Gaining =15 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [6] 0 0
Percentage of Participants Gaining =10 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [6] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [7] 0 0
Percentage of Participants Gaining =5 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [7] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [8] 0 0
Percentage of Participants Gaining =0 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [9] 0 0
Percentage of Participants Avoiding a Loss of =15, =10, or =5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [9] 0 0
Baseline, average of Weeks 40, 44, and 48
Secondary outcome [10] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Timepoint [10] 0 0
Baseline, average of Weeks 52, 56, and 60
Secondary outcome [11] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [12] 0 0
Percentage of Participants Avoiding a Loss of =10 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [12] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [13] 0 0
Percentage of Participants Avoiding a Loss of =5 Letters From the Baseline BCVA in the Study Eye Over Time
Timepoint [13] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [14] 0 0
Percentage of Participants Gaining =15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA =84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [14] 0 0
Baseline, average of Weeks 40, 44, and 48
Secondary outcome [15] 0 0
Percentage of Participants Gaining =15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA =84 Letters) in the Study Eye Over Time
Timepoint [15] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [16] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [16] 0 0
Baseline, average of Weeks 40, 44, and 48
Secondary outcome [17] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Over Time
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [18] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [18] 0 0
Baseline, average of Weeks 40, 44, and 48
Secondary outcome [19] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Over Time
Timepoint [19] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [20] 0 0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
Timepoint [20] 0 0
Week 48
Secondary outcome [21] 0 0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
Timepoint [21] 0 0
Week 60
Secondary outcome [22] 0 0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Timepoint [22] 0 0
Weeks 108 and 112
Secondary outcome [23] 0 0
Number of Study Drug Injections Received in the Study Eye Through Week 48
Timepoint [23] 0 0
From Baseline through Week 48
Secondary outcome [24] 0 0
Number of Study Drug Injections Received in the Study Eye Through Week 60
Timepoint [24] 0 0
From Baseline through Week 60
Secondary outcome [25] 0 0
Number of Study Drug Injections Received in the Study Eye Through Week 108
Timepoint [25] 0 0
From Baseline through Week 108
Secondary outcome [26] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
Timepoint [26] 0 0
From Baseline through Week 48
Secondary outcome [27] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
Timepoint [27] 0 0
From Baseline through Week 60
Secondary outcome [28] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Timepoint [28] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Secondary outcome [29] 0 0
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Timepoint [29] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Secondary outcome [30] 0 0
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Timepoint [30] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Secondary outcome [31] 0 0
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Timepoint [31] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Secondary outcome [32] 0 0
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Timepoint [32] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Secondary outcome [33] 0 0
Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time
Timepoint [33] 0 0
Up to 112 weeks
Secondary outcome [34] 0 0
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
Timepoint [34] 0 0
Baseline and Week 48
Secondary outcome [35] 0 0
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
Timepoint [35] 0 0
Baseline and Week 112
Secondary outcome [36] 0 0
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
Timepoint [36] 0 0
Baseline and Week 48
Secondary outcome [37] 0 0
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
Timepoint [37] 0 0
Baseline and Week 112
Secondary outcome [38] 0 0
Percentage of Participants With at Least One Adverse Event
Timepoint [38] 0 0
From first dose of study drug through end of study (up to 112 weeks)
Secondary outcome [39] 0 0
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Timepoint [39] 0 0
From first dose of study drug through end of study (up to 112 weeks)
Secondary outcome [40] 0 0
Percentage of Participants With at Least One Non-Ocular Adverse Event
Timepoint [40] 0 0
From first dose of study drug through end of study (up to 112 weeks)
Secondary outcome [41] 0 0
Plasma Concentration of Faricimab Over Time
Timepoint [41] 0 0
Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
Secondary outcome [42] 0 0
Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Timepoint [42] 0 0
Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112

Eligibility
Key inclusion criteria
* Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
* Ability to comply with the study protocol, in the investigator's judgment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
* Other protocol-specified inclusion criteria may apply
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* CNV due to causes other than AMD in the study eye
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
* Uncontrolled glaucoma in the study eye
* Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active ocular inflammation or suspected or active ocular or periocular infection in either eye
* Other protocol-specified exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2022
Sample size
Target
Accrual to date
Final
658
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Marsden Eye Research Centre - Parramatta
Recruitment hospital [3] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [4] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [5] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [6] 0 0
Sydney West Retina - Westmead
Recruitment hospital [7] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [8] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [9] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2135 - Strathfield
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3178 - Rowville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Caba
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Argentina
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Capital Federal
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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San Nicolás
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
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Austria
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Wien
Country [31] 0 0
Brazil
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GO
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Brazil
State/province [32] 0 0
SP
Country [33] 0 0
Bulgaria
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Sofia
Country [34] 0 0
China
State/province [34] 0 0
Beijing City
Country [35] 0 0
China
State/province [35] 0 0
Beijing
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China
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Changchun City
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China
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Chengdu
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China
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Chongqing City
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China
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Chongqing
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China
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Guangzhou City
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China
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Harbin
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China
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Nanjing City
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China
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Shanghai
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China
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Shenyang City
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China
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Tianjin City
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China
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Wenzhou City
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China
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Wuxi
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Denmark
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Glostrup
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Denmark
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Roskilde
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France
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Creteil
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France
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Ecully
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France
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Lyon cedex
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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St Cyr Sur Loire
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Germany
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Düsseldorf
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Germany
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Köln
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Germany
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Münster
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Hong Kong
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Hong Kong
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Hong Kong
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Mongkok
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Hungary
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Budapest
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Hungary
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Szeged
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Toscana
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Italy
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Veneto
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Tarnowskie Góry
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Portugal
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Braga
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Portugal
State/province [78] 0 0
Coimbra
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Portugal
State/province [79] 0 0
Porto
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Russian Federation
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Marij EL
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Russian Federation
State/province [81] 0 0
Irkutsk
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Russian Federation
State/province [82] 0 0
Novosibirsk
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Russian Federation
State/province [83] 0 0
Saint Petersburg
Country [84] 0 0
Singapore
State/province [84] 0 0
Singapore
Country [85] 0 0
Spain
State/province [85] 0 0
Asturias
Country [86] 0 0
Spain
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Barcelona
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Spain
State/province [87] 0 0
Valladolid
Country [88] 0 0
Spain
State/province [88] 0 0
Zaragoza
Country [89] 0 0
Taiwan
State/province [89] 0 0
Changhua
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taoyuan
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
Trial website
https://clinicaltrials.gov/study/NCT03823300
Trial related presentations / publications
Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03823300