KINGFISHER

Clinical Trials // Diabetic Macular Edema // Michael Altaweel // Ongoing // Jun 12 2019

A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients with Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)

  • Sponsor: Novartis Pharmaceuticals
  • Principal Investigator: Michael Altaweel, MD
  • Study Coordinator: Angie Adler

Study objective:

To evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema.

Study design:

Patients will be randomized in a 2:1 ratio (brolucizumab every 4 weeks: aflibercept every 4 weeks) and attend 15 planned visits (over the course of approximately 12 months).

Inclusion criteria:

  • 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
  • Any active intraocular or periocular infection or active intraocular inflammation in the either eye
  • Uncontrolled glaucoma in the study eye
  • 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

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov