KESTREL

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

Study objective:

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

Study design:

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).

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov