A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL)

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 in treatment of patients with visual impairment due to diabetic macular edema (DME).

Study Design:

In this 2-year, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 1:1:1 ratio to one of the three treatment arms (Brolucizumab 3 mg, Brolucizumab 6 mg, or Aflibercept 2 mg) and attend 28 planned visits.

Diagnosis and Key Eligibility Criteria:

Patients with type 1 or 2 diabetes mellitus over the age of 18 and HbA1c of ≤ 10% at screening, and medication for the management of diabetes stable within 3 months to randomization and is expected to remain stable during the course of the study.

Duration of Study: 2 years

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