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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740905

Registration number

NCT04740905

Ethics application status

Date submitted

3/02/2021

Date registered

5/02/2021

Date last updated

6/08/2024

Titles & IDs

Public title

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

Scientific title

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

Secondary ID [1]

2020-000440-63

Secondary ID [2]

GR41984

Universal Trial Number (UTN)

Trial acronym

BALATON

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Macular Edema

Branch Retinal Vein Occlusion

Condition category

Condition code

Eye

Diseases / disorders of the eye

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Faricimab
Treatment: Drugs - Aflibercept
Treatment: Surgery - Sham Procedure

Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

Active comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.

Treatment: Drugs: Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) 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 treatments arms at applicable visits to maintain masking.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24

Timepoint [1]

From Baseline through Week 24

Secondary outcome [1]

Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24

Timepoint [1]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [2]

Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Week 24

Timepoint [2]

Baseline and Week 24

Secondary outcome [3]

Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [3]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [4]

Part 1: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [4]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [5]

Part 1: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [5]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [6]

Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [6]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [7]

Part 1: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [7]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [8]

Part 1: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [8]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [9]

Part 1: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24

Timepoint [9]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [10]

Part 1: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

Timepoint [10]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [11]

Part 1: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

Timepoint [11]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [12]

Part 1: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

Timepoint [12]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [13]

Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24

Timepoint [13]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [14]

Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24

Timepoint [14]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [15]

Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

Timepoint [15]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [16]

Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

Timepoint [16]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [17]

Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

Timepoint [17]

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcome [18]

Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24

Timepoint [18]

Baseline and Week 24

Secondary outcome [19]

Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72

Timepoint [19]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [20]

Parts 1 and 2: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [20]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [21]

Parts 1 and 2: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [21]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [22]

Parts 1 and 2: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [22]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [23]

Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [23]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [24]

Parts 1 and 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [24]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [25]

Parts 1 and 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [25]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [26]

Parts 1 and 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72

Timepoint [26]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [27]

Parts 1 and 2: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

Timepoint [27]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [28]

Parts 1 and 2: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

Timepoint [28]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [29]

Parts 1 and 2: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

Timepoint [29]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [30]

Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72

Timepoint [30]

Baseline and Weeks 24, 48, and 72

Secondary outcome [31]

Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72

Timepoint [31]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [32]

Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72

Timepoint [32]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [33]

Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

Timepoint [33]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [34]

Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

Timepoint [34]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [35]

Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

Timepoint [35]

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [36]

Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72

Timepoint [36]

Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [37]

Part 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72

Timepoint [37]

Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [38]

Part 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72

Timepoint [38]

Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [39]

Part 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72

Timepoint [39]

Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [40]

Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72

Timepoint [40]

Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Secondary outcome [41]

Part 2: Percentage of Participants on Different Treatment Intervals at Week 68

Timepoint [41]

Week 68

Secondary outcome [42]

Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72

Timepoint [42]

From Week 24 to Week 72

Secondary outcome [43]

Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale

Timepoint [43]

Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

Secondary outcome [44]

Incidence of Ocular Adverse Events in the Fellow Eye

Timepoint [44]

Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

Secondary outcome [45]

Incidence of Non-Ocular Adverse Events

Timepoint [45]

Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

Secondary outcome [46]

Plasma Concentration of Faricimab Over Time

Timepoint [46]

Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Secondary outcome [47]

Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study

Timepoint [47]

Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Eligibility

Key inclusion criteria

* Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
* Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Any major illness or major surgical procedure within 1 month before screening
* Uncontrolled blood pressure
* Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
* Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

* History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
* Macular laser (focal/grid) in the study eye at any time prior to Day 1
* Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
* Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
* Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
* Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

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

2/03/2021

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

12/06/2023

Sample size

Target

Accrual to date

Final

553

Recruitment in Australia

Recruitment state(s)

NSW,VIC,WA

Recruitment hospital [1]

Strathfield Retina Clinic - Strathfield

Recruitment hospital [2]

Save Sight Institute - Sydney

Recruitment hospital [3]

Sydney Retina Clinic and Day Surgery - Sydney

Recruitment hospital [4]

Centre For Eye Research Australia - East Melbourne

Recruitment hospital [5]

Retina Specialists Victoria - Rowville

Recruitment hospital [6]

The Lions Eye Institute - Nedlands

Recruitment postcode(s) [1]

2135 - Strathfield

Recruitment postcode(s) [2]

2000 - Sydney

Recruitment postcode(s) [3]

3002 - East Melbourne

Recruitment postcode(s) [4]

3178 - Rowville

Recruitment postcode(s) [5]

6009 - Nedlands

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

Colorado

Country [4]

United States of America

State/province [4]

Connecticut

Country [5]

United States of America

State/province [5]

Florida

Country [6]

United States of America

State/province [6]

Georgia

Country [7]

United States of America

State/province [7]

Hawaii

Country [8]

United States of America

State/province [8]

Illinois

Country [9]

United States of America

State/province [9]

Maryland

Country [10]

United States of America

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Massachusetts

Country [11]

United States of America

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Michigan

Country [12]

United States of America

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Minnesota

Country [13]

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Missouri

Country [14]

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Nevada

Country [15]

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New Jersey

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New York

Country [17]

United States of America

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North Carolina

Country [18]

United States of America

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Ohio

Country [19]

United States of America

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South Dakota

Country [20]

United States of America

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Tennessee

Country [21]

United States of America

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Texas

Country [22]

United States of America

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Utah

Country [23]

Argentina

State/province [23]

Caba

Country [24]

Argentina

State/province [24]

Capital Federal

Country [25]

Argentina

State/province [25]

Ciudad Autonoma Buenos Aires

Country [26]

Argentina

State/province [26]

Mendoza

Country [27]

Argentina

State/province [27]

Rosario

Country [28]

Argentina

State/province [28]

San Nicolás

Country [29]

Austria

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Graz

Country [30]

Brazil

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Brazil

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Country [32]

Brazil

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Country [33]

China

State/province [33]

Beijing

Country [34]

China

State/province [34]

Changchun

Country [35]

China

State/province [35]

Chengdu

Country [36]

China

State/province [36]

Guangzhou City

Country [37]

China

State/province [37]

Harbin

Country [38]

China

State/province [38]

Nanjing City

Country [39]

China

State/province [39]

Shanghai

Country [40]

China

State/province [40]

Shenyang City

Country [41]

China

State/province [41]

Tianjin City

Country [42]

China

State/province [42]

Wenzhou City

Country [43]

China

State/province [43]

Wuhan

Country [44]

China

State/province [44]

Zhengzhou

Country [45]

Czechia

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Ostrava

Country [46]

Czechia

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Prague

Country [47]

Czechia

State/province [47]

Sokolov

Country [48]

France

State/province [48]

Creteil

Country [49]

France

State/province [49]

Paris

Country [50]

Germany

State/province [50]

Freiburg

Country [51]

Germany

State/province [51]

Göttingen

Country [52]

Germany

State/province [52]

Ludwigshafen

Country [53]

Hong Kong

State/province [53]

Hong Kong

Country [54]

Hong Kong

State/province [54]

Mongkok

Country [55]

Hungary

State/province [55]

Budapest

Country [56]

Hungary

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Debrecen

Country [57]

Hungary

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Pécs

Country [58]

Hungary

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Szeged

Country [59]

Israel

State/province [59]

Haifa

Country [60]

Israel

State/province [60]

Jerusalem

Country [61]

Israel

State/province [61]

Petach Tikva

Country [62]

Israel

State/province [62]

Rehovot

Country [63]

Israel

State/province [63]

Tel Aviv

Country [64]

Italy

State/province [64]

Lazio

Country [65]

Italy

State/province [65]

Lombardia

Country [66]

Italy

State/province [66]

Toscana

Country [67]

Japan

State/province [67]

Aichi

Country [68]

Japan

State/province [68]

Chiba

Country [69]

Japan

State/province [69]

Fukuoka

Country [70]

Japan

State/province [70]

Fukushima

Country [71]

Japan

State/province [71]

Hokkaido

Country [72]

Japan

State/province [72]

Hyogo

Country [73]

Japan

State/province [73]

Ibaraki

Country [74]

Japan

State/province [74]

Kyoto

Country [75]

Japan

State/province [75]

Tokushima

Country [76]

Japan

State/province [76]

Tokyo

Country [77]

Korea, Republic of

State/province [77]

Busan

Country [78]

Korea, Republic of

State/province [78]

Daegu

Country [79]

Korea, Republic of

State/province [79]

Seongnam-si

Country [80]

Korea, Republic of

State/province [80]

Seoul

Country [81]

Poland

State/province [81]

Bydgoszcz

Country [82]

Poland

State/province [82]

Bytom

Country [83]

Poland

State/province [83]

Gda?sk

Country [84]

Poland

State/province [84]

Gliwice

Country [85]

Poland

State/province [85]

Katowice

Country [86]

Poland

State/province [86]

Kraków

Country [87]

Poland

State/province [87]

Piaseczno

Country [88]

Poland

State/province [88]

Rybnik

Country [89]

Poland

State/province [89]

Tarnowskie Góry

Country [90]

Poland

State/province [90]

Warszawa

Country [91]

Portugal

State/province [91]

Coimbra

Country [92]

Portugal

State/province [92]

Porto

Country [93]

Russian Federation

State/province [93]

Baskortostan

Country [94]

Russian Federation

State/province [94]

Tatarstan

Country [95]

Russian Federation

State/province [95]

Irkutsk

Country [96]

Singapore

State/province [96]

Singapore

Country [97]

Spain

State/province [97]

Navarra

Country [98]

Spain

State/province [98]

Valencia

Country [99]

Spain

State/province [99]

Barcelona

Country [100]

Spain

State/province [100]

Madrid

Country [101]

Spain

State/province [101]

Valladolid

Country [102]

Taiwan

State/province [102]

Changhua

Country [103]

Taiwan

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Taipei

Country [104]

Taiwan

State/province [104]

Taoyuan

Country [105]

Taiwan

State/province [105]

Zhongzheng Dist.

Country [106]

United Kingdom

State/province [106]

Belfast

Country [107]

United Kingdom

State/province [107]

Bristol

Country [108]

United Kingdom

State/province [108]

Cardiff

Country [109]

United Kingdom

State/province [109]

Gloucestershire

Country [110]

United Kingdom

State/province [110]

Leeds

Country [111]

United Kingdom

State/province [111]

London

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Hoffmann-La Roche

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Chugai Pharmaceutical

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

Trial website

https://clinicaltrials.gov/study/NCT04740905

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Trials

Address

Hoffmann-La Roche

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04740905

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740905