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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03622593




Registration number
NCT03622593
Ethics application status
Date submitted
1/08/2018
Date registered
9/08/2018
Date last updated
4/06/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
Secondary ID [1] 0 0
2017-005105-12
Secondary ID [2] 0 0
GR40398
Universal Trial Number (UTN)
Trial acronym
RHINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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

Experimental: A: Faricimab 6 mg Q8W - Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.

Experimental: B: Faricimab 6 mg PTI - Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.

Active Comparator: C: Aflibercept 2 mg Q8W - Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.


Treatment: Drugs: Aflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Treatment: Drugs: Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.

Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
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 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [1] 0 0
From Baseline through Week 56
Secondary outcome [1] 0 0
Percentage of Participants With a =2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [3] 0 0
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Timepoint [3] 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, and 100
Secondary outcome [4] 0 0
Percentage of Participants Gaining Greater Than or Equal to (=)15, =10, =5, or =0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Timepoint [4] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [5] 0 0
Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [6] 0 0
Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [7] 0 0
Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [8] 0 0
Percentage of Participants Gaining =0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [9] 0 0
Percentage of Participants Gaining =15, =10, =5, or =0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Timepoint [9] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [10] 0 0
Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Timepoint [10] 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, and 100
Secondary outcome [11] 0 0
Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
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, and 100
Secondary outcome [12] 0 0
Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
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, and 100
Secondary outcome [13] 0 0
Percentage of Participants Gaining =0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
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, and 100
Secondary outcome [14] 0 0
Percentage of Participants Avoiding a Loss of =15, =10, or =5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Timepoint [14] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [15] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [16] 0 0
Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Timepoint [16] 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, and 100
Secondary outcome [17] 0 0
Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
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, and 100
Secondary outcome [18] 0 0
Percentage of Participants Avoiding a Loss of =15, =10, or =5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Timepoint [18] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [19] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
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, and 100
Secondary outcome [20] 0 0
Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Timepoint [20] 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, and 100
Secondary outcome [21] 0 0
Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Timepoint [21] 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, and 100
Secondary outcome [22] 0 0
Percentage of Participants Gaining =15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA =84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [22] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [23] 0 0
Percentage of Participants Gaining =15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA =84 Letters) in the Study Eye Over Time, ITT Population
Timepoint [23] 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, and 100
Secondary outcome [24] 0 0
Percentage of Participants Gaining =15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA =84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Timepoint [24] 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, and 100
Secondary outcome [25] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [25] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [26] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Over Time, ITT Population
Timepoint [26] 0 0
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, and 100
Secondary outcome [27] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Timepoint [27] 0 0
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, and 100
Secondary outcome [28] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [28] 0 0
Baseline, average of Weeks 48, 52, and 56
Secondary outcome [29] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Over Time, ITT Population
Timepoint [29] 0 0
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, and 100
Secondary outcome [30] 0 0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Timepoint [30] 0 0
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, and 100
Secondary outcome [31] 0 0
Percentage of Participants With a =2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Timepoint [31] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [32] 0 0
Percentage of Participants With a =2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Timepoint [32] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [33] 0 0
Percentage of Participants With a =3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Timepoint [33] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [34] 0 0
Percentage of Participants With a =3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Timepoint [34] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [35] 0 0
Percentage of Participants With a =4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Timepoint [35] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [36] 0 0
Percentage of Participants With a =4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Timepoint [36] 0 0
Baseline, Weeks 16, 52, and 96
Secondary outcome [37] 0 0
Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
Timepoint [37] 0 0
Baseline and Week 52
Secondary outcome [38] 0 0
Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
Timepoint [38] 0 0
Baseline and Week 52
Secondary outcome [39] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Timepoint [39] 0 0
Week 52
Secondary outcome [40] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Timepoint [40] 0 0
Week 52
Secondary outcome [41] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Timepoint [41] 0 0
Week 96
Secondary outcome [42] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Timepoint [42] 0 0
Week 96
Secondary outcome [43] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Timepoint [43] 0 0
From start of PTI (Week 12 or later) until Week 52
Secondary outcome [44] 0 0
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Timepoint [44] 0 0
From start of PTI (Week 12 or later) until Week 96
Secondary outcome [45] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [45] 0 0
From Baseline through Week 56
Secondary outcome [46] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Timepoint [46] 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, and 100
Secondary outcome [47] 0 0
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Timepoint [47] 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, and 100
Secondary outcome [48] 0 0
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Timepoint [48] 0 0
Average of Weeks 48, 52, and 56
Secondary outcome [49] 0 0
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Timepoint [49] 0 0
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, and 100
Secondary outcome [50] 0 0
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Timepoint [50] 0 0
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, and 100
Secondary outcome [51] 0 0
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Timepoint [51] 0 0
Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Secondary outcome [52] 0 0
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Timepoint [52] 0 0
Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Secondary outcome [53] 0 0
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Timepoint [53] 0 0
Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Secondary outcome [54] 0 0
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
Timepoint [54] 0 0
Baseline, Weeks 24, 52, and 100
Secondary outcome [55] 0 0
Percentage of Participants With at Least One Adverse Event
Timepoint [55] 0 0
From first dose of study drug through end of study (up to 2 years)
Secondary outcome [56] 0 0
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Timepoint [56] 0 0
From first dose of study drug through end of study (up to 2 years)
Secondary outcome [57] 0 0
Percentage of Participants With at Least One Non-Ocular Adverse Event
Timepoint [57] 0 0
From first dose of study drug through end of study (up to 2 years)
Secondary outcome [58] 0 0
Plasma Concentration of Faricimab Over Time
Timepoint [58] 0 0
Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100
Secondary outcome [59] 0 0
Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Timepoint [59] 0 0
Baseline, Weeks 4, 28, 52, 76, and 100

Eligibility
Key inclusion criteria
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)

- Hemoglobin A1c (HbA1c) of less than or equal to (=)10% within 2 months prior to Day 1

- Macular thickening secondary to diabetic macular edema (DME) involving the center of
the fovea

- Decreased visual acuity attributable primarily to DME

- Ability and willingness to undertake all scheduled visits and assessments

- For women of childbearing potential: agreement to remain abstinent or use acceptable
contraceptive methods that result in a failure rate of <1% per year during the
treatment period and for at least 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?
No
Key exclusion criteria
- Currently untreated diabetes mellitus or previously untreated patients who initiated
oral or injectable anti-diabetic medication within 3 months prior to Day 1

- Uncontrolled blood pressure, defined as a systolic value greater than (>)180
millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at
rest

- Currently pregnant or breastfeeding, or intend to become pregnant during the study

- Treatment with panretinal photocoagulation or macular laser within 3 months prior to
Day 1 to the study eye

- Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1
to the study eye

- Prior administration of IVT faricimab in either eye

- Active intraocular or periocular infection or active intraocular inflammation in the
study eye

- Any current or history of ocular disease other than DME that may confound assessment
of the macula or affect central vision in the study eye

- 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 DME in the study eye

- Other protocol-specified inclusion/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
9/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
951
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [2] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [4] 0 0
Sydney West Retina - Westmead
Recruitment hospital [5] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [6] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [7] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3178 - Rowville
Recruitment postcode(s) [6] 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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Caba
Country [23] 0 0
Argentina
State/province [23] 0 0
Capital Federal
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
San Nicolás
Country [27] 0 0
Brazil
State/province [27] 0 0
GO
Country [28] 0 0
Brazil
State/province [28] 0 0
RS
Country [29] 0 0
Brazil
State/province [29] 0 0
SC
Country [30] 0 0
Brazil
State/province [30] 0 0
SP
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
China
State/province [36] 0 0
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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, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation, compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03622593
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT03622593