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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03823300
Ethics application status
Date submitted
29/01/2019
Date registered
30/01/2019
Date last updated
12/08/2019

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: Drugs - Sham Procedure

Experimental: Faricimab -

Active Comparator: 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: Drugs: 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48 - BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
Timepoint [1] 0 0
From Baseline up to 48 weeks
Secondary outcome [1] 0 0
Change from Baseline in BCVA Over Time
Timepoint [1] 0 0
From Baseline up to 112 weeks
Secondary outcome [2] 0 0
Percentage of Participants Gaining =15 Letters in BCVA from Baseline Over Time
Timepoint [2] 0 0
From Baseline up to 112 weeks
Secondary outcome [3] 0 0
Percentage of Participants Gaining =10 Letters in BCVA from Baseline Over Time
Timepoint [3] 0 0
From Baseline up to 112 weeks
Secondary outcome [4] 0 0
Percentage of Participants Gaining =5 Letters in BCVA from Baseline Over Time
Timepoint [4] 0 0
From Baseline up to 112 weeks
Secondary outcome [5] 0 0
Percentage of Participants Gaining =0 Letters in BCVA from Baseline Over Time
Timepoint [5] 0 0
From Baseline up to 112 weeks
Secondary outcome [6] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters in BCVA from Baseline Over Time
Timepoint [6] 0 0
From Baseline up to 112 weeks
Secondary outcome [7] 0 0
Percentage of Participants Avoiding a Loss of =10 Letters in BCVA from Baseline Over Time
Timepoint [7] 0 0
From Baseline up to 112 weeks
Secondary outcome [8] 0 0
Percentage of Participants Avoiding a Loss of =5 Letters in BCVA from Baseline Over Time
Timepoint [8] 0 0
From Baseline up to 112 weeks
Secondary outcome [9] 0 0
Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline Over Time
Timepoint [9] 0 0
From Baseline up to 112 weeks
Secondary outcome [10] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Timepoint [10] 0 0
Up to 112 weeks
Secondary outcome [11] 0 0
Percentage of Participants Gaining =15 Letters or Achieving BCVA of =84 Letters Over Time
Timepoint [11] 0 0
Up to 112 weeks
Secondary outcome [12] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Timepoint [12] 0 0
Up to 112 weeks
Secondary outcome [13] 0 0
Percentage of Participants on Different Treatment Intervals at Weeks 48, 60, and 112
Timepoint [13] 0 0
Weeks 48, 60, and 112
Secondary outcome [14] 0 0
Number of Study Drug Injections Received Through Weeks 48, 60, and 112
Timepoint [14] 0 0
Weeks 48, 60, and 112
Secondary outcome [15] 0 0
Average Change from Baseline in Central Subfield Thickness (CST) at Week 48
Timepoint [15] 0 0
From Baseline up to 48 weeks
Secondary outcome [16] 0 0
Change from Baseline in CST Over Time
Timepoint [16] 0 0
From Baseline up to 112 weeks
Secondary outcome [17] 0 0
Percentage of Participants with Absence of Intraretinal Fluid Over Time
Timepoint [17] 0 0
Up to 112 weeks
Secondary outcome [18] 0 0
Percentage of Participants with Absence of Subretinal Fluid Over Time
Timepoint [18] 0 0
Up to 112 weeks
Secondary outcome [19] 0 0
Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
Timepoint [19] 0 0
Up to 112 weeks
Secondary outcome [20] 0 0
Percentage of Participants with Absence of Intraretinal Cysts Over Time
Timepoint [20] 0 0
Up to 112 weeks
Secondary outcome [21] 0 0
Percentage of Participants with Absence of Pigment Epithelial Detachment Over Time
Timepoint [21] 0 0
Up to 112 weeks
Secondary outcome [22] 0 0
Change from Baseline in Total Area of Choroidal Neovascularization (CNV) Lesion at Weeks 48 and 112
Timepoint [22] 0 0
Baseline, Weeks 48 and 112
Secondary outcome [23] 0 0
Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112
Timepoint [23] 0 0
Baseline, Weeks 48 and 112
Secondary outcome [24] 0 0
Percentage of Participants with Ocular Adverse Events
Timepoint [24] 0 0
Up to 116 weeks
Secondary outcome [25] 0 0
Percentage of Participants with Non-Ocular Adverse Events
Timepoint [25] 0 0
Up to 116 weeks
Secondary outcome [26] 0 0
Plasma Concentration of Faricimab Over Time
Timepoint [26] 0 0
Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
Secondary outcome [27] 0 0
Percentage of Participants with Presence of Anti-Drug Antibodies
Timepoint [27] 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Arizona
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United States of America
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California
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Colorado
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Florida
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United States of America
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Georgia
Country [6] 0 0
United States of America
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Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
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Indiana
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United States of America
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Iowa
Country [10] 0 0
United States of America
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Kansas
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United States of America
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Maine
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United States of America
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Maryland
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Massachusetts
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Minnesota
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Nevada
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New Jersey
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United States of America
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New York
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Ohio
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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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Vermont
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Virginia
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Washington
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Argentina
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Buenos Aires
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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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Mendoza
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Argentina
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Rosario
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Austria
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Graz
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Austria
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Linz
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Austria
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Wien
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Brazil
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SP
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Bulgaria
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Sofia
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Varna
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China
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Beijing City
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China
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Beijing
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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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Nanjing City
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China
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Shanghai
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China
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Tianjin City
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China
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Wuxi
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Denmark
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Aalborg
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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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Dijon
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Ecully
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Lyon cedex
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Nantes
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Bonn
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Hannover
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Köln
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Münster
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Mongkok
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Budapest
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Hungary
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Szeged
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Lazio
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Italy
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Liguria
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Lombardia
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Sicilia
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Daegu
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Gyeonggi-do
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Seoul
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Poland
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Bydgoszcz
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Gdansk
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Krakow
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Tarnowskie Góry
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Porto
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Russian Federation
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Marij EL
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Irkutsk
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Valladolid
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Spain
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Zaragoza
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Taiwan
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Changhua
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Turkey
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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/show/NCT03823300
Trial related presentations / publications
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
Reference Study ID Number: GR40844 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6782 (U.S. Only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

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