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)

Active Clinical Trials // Jun 12 2019

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

Study Objective:

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

Study Design:

In this 12-month, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 2:1 ratio (brolucizumab: aflibercept) and attend 15 planned visits.

Diagnosis and Key Eligibility Criteria:

Patients over the age of 18 with type 1 or 2 diabetes mellitus, HbA1c of ≤ 12% at screening, with visual impairment due to DME between (approximate Snellen equivalent of 20/32 to 20/320) at screening. Previous use of anti-VEGF therapies, intraocular surgery or laser photocoagulation is allowed, but must have occurred > 3 months prior to baseline.

Duration of Study: 12 months

 For more information, contact Angie Adler 608-265-7557.