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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/NCT03810313
Registration number
NCT03810313
Ethics application status
Date submitted
17/01/2019
Date registered
18/01/2019
Date last updated
30/01/2023
Titles & IDs
Public title
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
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Scientific title
An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
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Secondary ID [1]
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2018-001788-21
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Secondary ID [2]
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CRTH258C2302
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Universal Trial Number (UTN)
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Trial acronym
RAVEN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central Retinal Vein Occlusion
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Brolucizumab 6 mg
Treatment: Drugs - Aflibercept 2 mg
Other interventions - Sham injection
Experimental: Brolucizumab 6 mg - 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Active Comparator: Aflibercept 2 mg - 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Treatment: Drugs: Brolucizumab 6 mg
Solution for injection (intravitreal use)
Treatment: Drugs: Aflibercept 2 mg
Solution for injection (Intravitreal use)
Other interventions: Sham injection
Empty sterile syringe without a needle administered as a sham injection for masking. From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24
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Assessment method [1]
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BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [1]
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Change From Baseline in BCVA Averaged Over Week 40 to Week 52
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Assessment method [1]
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An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
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Timepoint [1]
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Baseline, Week 40 to Week 52
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Secondary outcome [2]
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Change From Baseline in BCVA Averaged Over Week 64 to Week 76
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Assessment method [2]
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An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
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Timepoint [2]
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Baseline, Week 64 to Week 76
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Secondary outcome [3]
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Change From Baseline in BCVA by Visit up to Week 76
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Assessment method [3]
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BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
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Timepoint [3]
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Baseline and every 4 weeks from baseline up to Week 76
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Secondary outcome [4]
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Proportion of Participants With a Gain = 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline
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Assessment method [4]
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The summary by visit was conducted based on the BCVA observed from each of the corresponding visits.
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Every 5 letters represents 1 line of vision on the reading chart.
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Timepoint [4]
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Baseline and every 4 weeks from baseline up to Week 76
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Secondary outcome [5]
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Proportion of Participants With a Loss = 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline
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Assessment method [5]
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The summary by visit was conducted based on the BCVA observed from each of the corresponding visit.
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Every 5 letters represents 1 line of vision on the reading chart.
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Timepoint [5]
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Baseline and every 4 weeks from baseline up to Week 76
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Secondary outcome [6]
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Change From Baseline in CSFT Averaged Over Week 40 to Week 52
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Assessment method [6]
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Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
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Timepoint [6]
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Baseline, Week 40 to Week 52
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Secondary outcome [7]
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Change From Baseline in CSFT Averaged Over Week 64 to Week 76
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Assessment method [7]
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Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
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Timepoint [7]
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Baseline, Week 64 to Week 76
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Secondary outcome [8]
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Change From Baseline in CSFT by Visit up to Week 76
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Assessment method [8]
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Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
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Timepoint [8]
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Baseline, and every 4 weeks from baseline up to Week 76
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Secondary outcome [9]
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Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76
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Assessment method [9]
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Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
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Timepoint [9]
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Every 4 weeks from week 4 up to Week 76
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Secondary outcome [10]
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Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76
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Assessment method [10]
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Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
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Timepoint [10]
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Every 4 weeks from week 4 up to Week 76
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Secondary outcome [11]
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Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72
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Assessment method [11]
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Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented
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Timepoint [11]
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Week 24 to Week 52 and Week 24 to Week 72
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Secondary outcome [12]
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Time to Recurrence After Week 20 and up to Week 76
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Assessment method [12]
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Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76.
For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).
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Timepoint [12]
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Week 20 to Week 76
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Secondary outcome [13]
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Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76
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Assessment method [13]
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Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).
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Timepoint [13]
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Baseline to Week 76
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Secondary outcome [14]
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Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76
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Assessment method [14]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL).
The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.
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Timepoint [14]
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Baseline, Week 24, Week 52 and Week 76
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Secondary outcome [15]
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Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76
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Assessment method [15]
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Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.
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Timepoint [15]
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Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76
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Eligibility
Key inclusion criteria
- Signed informed consent must be obtained prior to participation in the study.
- Patients with visual impairment due to ME secondary to CRVO diagnosed < 6 months prior
to screening.
- BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing
charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and
baseline visits.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
- Concomitant conditions or ocular disorders in the study eye at screening or baseline
which could, in the opinion of the investigator, prevent response to study treatment
or may confound interpretation of study results, compromise visual acuity or require
medical or surgical intervention during the first 12-month study period (e.g.
structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other
than CRVO, retinal detachment, macular hole, or choroidal neovascularization of any
cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular
edema).
- Any active intraocular or periocular infection or active intraocular inflammation
(e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious
blepharitis, uveitis) in study eye at screening or baseline
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg
on medication, or according to investigator's judgment, at screening or baseline
- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <
20/200 at screening (except when due to conditions whose surgery may improve VA, e.g.
cataract)
- Previous treatment with any anti-VEGF therapy or investigational drugs in the study
eye at any time prior to baseline
- Previous use of intraocular or periocular steroids in study eye at any time prior to
baseline
- Macular laser photocoagulation (focal/grid) in the study eye at any time prior to
baseline and peripheral laser photocoagulation in the study eye within 3 months prior
to the baseline
- Intraocular surgery in the study eye during the 3-month period prior to baseline
- Vitreoretinal surgery in the study eye at any time prior to baseline
- Aphakia with the absence of posterior capsule in the study eye
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/07/2021
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Sample size
Target
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Accrual to date
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Final
493
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Albury
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Recruitment hospital [2]
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Novartis Investigative Site - Parramatta
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Recruitment hospital [3]
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Novartis Investigative Site - Strathfield
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Recruitment hospital [4]
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Novartis Investigative Site - Sydney
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Recruitment hospital [5]
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Novartis Investigative Site - Hobart
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Recruitment hospital [6]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [7]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2150 - Parramatta
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Recruitment postcode(s) [3]
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2135 - Strathfield
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Recruitment postcode(s) [4]
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2000 - Sydney
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Recruitment postcode(s) [5]
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7000 - Hobart
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Recruitment postcode(s) [6]
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3002 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Wisconsin
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Alberta
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Canada
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Ontario
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Canada
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China
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Guangdong
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China
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Heilongjiang
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China
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Hubei
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China
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Jiangsu
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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China
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Beijing
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China
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Chongqing
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CZE
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Pardubice
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Czechia
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Praha 10
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Czechia
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Praha
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France
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Creteil
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France
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Dijon
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France
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Nantes
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France
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Paris cedex 10
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France
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Paris Cedex 19
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Bavaria
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Germany
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Duesseldorf
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Freiburg
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Gottingen
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Hannover
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Muenster
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Germany
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Ulm
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Greece
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GR
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Greece
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Heraklion Crete
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Hungary
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Baranya
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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BA
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Italy
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MI
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Japan
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Aichi
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Japan
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Fukushima
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Japan
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Kagawa
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Japan
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Mie
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Tokyo
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Selangor
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Netherlands
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Tilburg
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Puerto Rico
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Arecibo
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Russian Federation
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Cheboksary
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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St-Petersburg
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Spain
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Pais Vasco
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Thailand
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State/province [80]
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Hat Yai
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Thailand
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State/province [81]
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THA
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Country [82]
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Thailand
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Bangkok
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Country [83]
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Turkey
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State/province [83]
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Ankara
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Country [84]
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United Kingdom
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State/province [84]
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Suffolk
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Country [85]
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United Kingdom
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State/province [85]
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Leeds
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Country [86]
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United Kingdom
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State/province [86]
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Liverpool
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Country [87]
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United Kingdom
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State/province [87]
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London
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Country [88]
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United Kingdom
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State/province [88]
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in
treatment of patients with macular edema (ME) secondary to central retinal vein occlusion
(CRVO).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03810313
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03810313
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