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
To evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema.
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 (over the course of approximately 2 years).
Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the study
Active proliferative diabetic retinopathy in the study eye
Active intraocular or periocular infection or active intraocular inflammation in study eye
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
Stroke or myocardial infarction during the 6-month period prior to baseline
Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg