Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03622593
Ethics application status
Date submitted
1/08/2018
Date registered
9/08/2018

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
Beijing City
Country [37] 0 0
China
State/province [37] 0 0
Beijing
Country [38] 0 0
China
State/province [38] 0 0
Changchun
Country [39] 0 0
China
State/province [39] 0 0
Chengdu
Country [40] 0 0
China
State/province [40] 0 0
Chongqing City
Country [41] 0 0
China
State/province [41] 0 0
Guangzhou City
Country [42] 0 0
China
State/province [42] 0 0
Nanjing City
Country [43] 0 0
China
State/province [43] 0 0
Shanghai
Country [44] 0 0
China
State/province [44] 0 0
Tianjin City
Country [45] 0 0
China
State/province [45] 0 0
Wenzhou City
Country [46] 0 0
China
State/province [46] 0 0
Wuxi
Country [47] 0 0
Czechia
State/province [47] 0 0
Hradec Králové
Country [48] 0 0
Czechia
State/province [48] 0 0
Ostrava
Country [49] 0 0
Czechia
State/province [49] 0 0
Prague
Country [50] 0 0
Czechia
State/province [50] 0 0
Sokolov
Country [51] 0 0
Denmark
State/province [51] 0 0
Aalborg
Country [52] 0 0
Denmark
State/province [52] 0 0
Glostrup
Country [53] 0 0
Denmark
State/province [53] 0 0
Roskilde
Country [54] 0 0
France
State/province [54] 0 0
Creteil
Country [55] 0 0
France
State/province [55] 0 0
Dijon
Country [56] 0 0
France
State/province [56] 0 0
Lyon cedex
Country [57] 0 0
France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
St Cyr Sur Loire
Country [59] 0 0
France
State/province [59] 0 0
Toulouse
Country [60] 0 0
Germany
State/province [60] 0 0
Dresden
Country [61] 0 0
Germany
State/province [61] 0 0
Freiburg
Country [62] 0 0
Germany
State/province [62] 0 0
Homburg/Saar
Country [63] 0 0
Germany
State/province [63] 0 0
Magdeburg
Country [64] 0 0
Germany
State/province [64] 0 0
München
Country [65] 0 0
Germany
State/province [65] 0 0
Würzburg
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Hong Kong
Country [67] 0 0
Hong Kong
State/province [67] 0 0
Mongkok
Country [68] 0 0
Hungary
State/province [68] 0 0
Budapest
Country [69] 0 0
Italy
State/province [69] 0 0
Lazio
Country [70] 0 0
Italy
State/province [70] 0 0
Lombardia
Country [71] 0 0
Italy
State/province [71] 0 0
Toscana
Country [72] 0 0
Italy
State/province [72] 0 0
Veneto
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Seongnam-si
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul
Country [75] 0 0
Poland
State/province [75] 0 0
Bydgoszcz
Country [76] 0 0
Poland
State/province [76] 0 0
Gda?sk
Country [77] 0 0
Poland
State/province [77] 0 0
Gliwice
Country [78] 0 0
Poland
State/province [78] 0 0
Krakow
Country [79] 0 0
Poland
State/province [79] 0 0
Rzeszów
Country [80] 0 0
Poland
State/province [80] 0 0
Tarnowskie Góry
Country [81] 0 0
Poland
State/province [81] 0 0
Warszawa
Country [82] 0 0
Portugal
State/province [82] 0 0
Braga
Country [83] 0 0
Portugal
State/province [83] 0 0
Coimbra
Country [84] 0 0
Portugal
State/province [84] 0 0
Lisboa
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Marij EL
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Tatarstan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Irkutsk
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Novosibirsk
Country [89] 0 0
Singapore
State/province [89] 0 0
Singapore
Country [90] 0 0
Spain
State/province [90] 0 0
Asturias
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Navarra
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Spain
State/province [94] 0 0
Madrid
Country [95] 0 0
Spain
State/province [95] 0 0
Valladolid
Country [96] 0 0
Switzerland
State/province [96] 0 0
Binningen
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan
Country [99] 0 0
Taiwan
State/province [99] 0 0
Zhongzheng Dist.
Country [100] 0 0
Thailand
State/province [100] 0 0
Bangkok
Country [101] 0 0
Thailand
State/province [101] 0 0
ChiangMai
Country [102] 0 0
Turkey
State/province [102] 0 0
Ankara
Country [103] 0 0
Turkey
State/province [103] 0 0
Istanbul
Country [104] 0 0
Turkey
State/province [104] 0 0
Kocaeli
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Barnet
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Belfast
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Bradford
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Bristol
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Canterbury
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Frimley
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Gloucestershire
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Leeds
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Liverpool
Country [114] 0 0
United Kingdom
State/province [114] 0 0
London
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Manchester
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Middx
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Newcastle upon Tyne
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Norfolk
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Southampton
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Sunderland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03622593