Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12%at screening.
• Study eye: Visual impairment due to DME with:
• Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive,using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testingcharts at an initial testing distance of 4 meters
• DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)

Exclusion Criteria:

• High-risk proliferative diabetic retinopathy (PDR) in the study eye
• Concomitant conditions or ocular disorders in the study eye which confoundinterpretation of study results, compromise visual acuity or require medical orsurgical intervention
• Any active intraocular or periocular infection or active intraocular inflammation inthe either eye
• Uncontrolled glaucoma in the study eye
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200
• Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular orpanretinal) in the study eye during the 3-month period prior to baseline
• Use of intraocular or periocular corticosteroids in the study eye during the 6-monthperiod prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
• Prior investigational drugs in either eye, vitreoretinal surgery in the study eye atany time prior to baseline