Clinical Trials // Diabetic Macular Edema // Michael Altaweel // Ongoing // Jun 12 2019
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)
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Michael Altaweel, MD
Study Coordinator: Angie Adler
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).
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