Last updated on June 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetic Macular Edema
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 m 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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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