A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Brolucizumab; Aflibercept
Intervention description: Intravitreal injection; Intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; intravitreal injection; brolucizumab; aflibercept; double-masked

Summary:

      This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm
      study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the
      active control, aflibercept 2 mg used per authorized label, in subjects with visual
      impairment due to diabetic macular edema (DME).
    

Eligibility criteria:

        Key Inclusion Criteria:

        General

          -  Patients must give written informed consent before any study related assessments are
             performed

          -  Patients with type 1 or type 2 diabetes mellitus and HbA1c of =< 10% at screening

          -  Medication for the management of diabetes must have been stable within 3 months prior
             to randomization and is expected to remain stable during the course of the study

        Study Eye

          -  Visual impairment due to DME with:

               1. BCVA score between 78 and 23 letters, inclusive, using Early Treatment Diabetic
                  Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4
                  meters (approximate Snellen equivalent of 20/32 to 20/320), at screening and
                  baseline

               2. DME involving the center of the macula, with central subfield retinal thickness
                  (measured from RPE to ILM inclusively) of >= 320 micrometers (μm) on SD-OCT at
                  screening If both eyes are eligible, the eye with the worse visual acuity will be
                  selected for study eye. However, the investigator may select the eye with better
                  visual acuity, based on medical reasons or local ethical requirements.

                  Key Exclusion Criteria:

          -  Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye

          -  Active proliferative diabetic retinopathy in the study eye as per the investigator

          -  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.,
             cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular
             hole, or choroidal neovascularization of any cause)

          -  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

          -  Structural damage of the fovea in the study eye at screening likely to preclude
             improvement in visual acuity following the resolution of macular edema, including
             atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s),
             epiretinal membrane involving fovea or organized hard exudate plaques

          -  Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
             millimeters mercury (mmHg) on medication or according to investigator's judgment, at
             screening or baseline

          -  Neovascularization of the iris in the study eye at screening or baseline

          -  Evidence of vitreomacular traction in the study eye at screening or baseline which, in
             the opinion of the investigator, affect visual acuity