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: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: A masked evaluating investigator will be responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator was to perform the injections and assess patient safety following the injections.
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; intravitreal injection; brolucizumab; aflibercept; double-masked; Diabetic Macular edema (DME); macular edema; diabetic retinopathy

Summary:

      The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs.
      aflibercept in the treatment of patients with visual impairment due to diabetic macular edema
      (DME).
    

Eligibility criteria:

        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 testing
                  charts 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 confound
             interpretation of study results, compromise visual acuity or require medical or
             surgical intervention

          -  Any active intraocular or periocular infection or active intraocular inflammation in
             the 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 or
             panretinal) 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-month
             period 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 at
             any time prior to baseline