Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Retinal Vein Occlusion
Intervention: Brolucizumab 6 mg; Aflibercept 2 mg; Sham injection
Intervention description: Solution for injection (intravitreal use); Solution for injection (Intravitreal use); Empty sterile syringe without a needle administered as a sham injection for masking purposes.
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.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: A masked evaluating investigator was responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator performed the injections and assessed patient safety following the injections.
Enrollment: 450.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Visual impairment; Macular edema; Branch retinal vein occlusion; BRVO; Brolucizumab; Aflibercept; Vascular endothelial growth factor; VEGF; anti-VEGF

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 branch retinal vein occlusion
      (BRVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent must be obtained prior to participation in the study.

          -  Patients with visual impairment due to ME secondary to BRVO 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.

        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 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.

          -  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