Central retinal vein occlusion MedDRA version: 20.0 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion System Organ Class: 100000004853
Conditions
Interventions
Trade Name: BEOVU
Product Name: Brolucizumab
Product Code: RTH258 formerly ESBA1008
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BROLUCIZUMAB
CAS Number: 1531589-13-5
Current Spons
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Signed informed consent must be obtained prior to participation in the study 2- Male or female patients to be 18 years of age or over at screening 3- Patients with visual impairment due to ME secondary to CRVO diagnosed less than 6 months prior to screening; hemiretinal vein occlusion will be classified as CRVO (study eye) 4- 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 (study eye) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 375
Exclusion criteria
Exclusion criteria: 1-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 BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded. 2-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 3-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 4-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) 5-Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline 6-Previous use of intraocular or periocular steroids in study eye at any time prior to baseline 7-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 8-Intraocular surgery in the study eye during the 3-month period prior to baseline 9-Vitreoretinal surgery in the study eye at any time prior to baseline 10-Aphakia with the absence of posterior capsule in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the change in visual acuity from baseline up to month 6;Secondary Objective: 1. To assess the effect of brolucizumab as compared to aflibercept on visual acuity 2. To evaluate the anatomical outcome with brolucizumab relative to aflibercept 3. To evaluate the treatment frequency with brolucizumab during the individualized flexible treatment (IFT) period relative to aflibercept 4. To assess the safety and tolerability of brolucizumab relative to aflibercept 5. To evaluate the effect of brolucizumab relative to aflibercept on patient-reported vision-related quality of life (VFQ-25) 6. To assess the immunogenicity of brolucizumab;Primary end point(s): Change from baseline in BCVA at Week 24;Timepoint(s) of evaluation of this end point: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. • Change from baseline in BCVA averaged over Week 40 to Week 52 and Week 64 to Week 76 • Change from baseline in BCVA by visit up to Week 76 • Proportion of study eyes with a gain = 5, 10 and 15 letters in BCVA by visit compared to baseline • Proportion of study eyes with a loss = 5, 10 and 15 letters in BCVA by visit compared to baseline 2. • Change from baseline in central subfield thickness (CSFT, derived from SD-OCT) averaged over Week 40 to Week 52 and Week 64 to Week 76 • Change from baseline in CSFT (derived from SD-OCT) by visit up to Week 76 • Proportion of study eyes with presence of retinal fluid (intra- and/or subretinal fluid) by visit up to Week 76 (derived from SD-OCT) • Proportion of study eyes with a CSFT < 300 µM (derived from SD-OCT) by visit up to Week 76 3. • Number of injections between Week 24 and Week 52 and between Week 24 and Week 76 • Time to first re-treatment between Week 24 and Week 76 4. • Incidence of ocular and non-ocular Adverse Events up to Week 52 and Week 76 5. • Change from baseline in patient reported outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 6. • Anti-drug antibody status at baseline and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 12, 24, 36, 40, 52, 64 and/or 76 | — |
Countries
Australia, Canada, China, Czechia, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Russian Federation, Spain, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o.
Outcome results
None listed