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