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Novartis KESTREL - Diabetic Macular Edema (DME)

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL)

Study Description:

Condition or Disease

Intervention / Treatment




Diabetic Macular Edema

Drug:  Brolucizumab

Drug:  Aflibercept

Phase 3



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.

Eligibility Criteria:

  • Ages Eligible for Study - 18 Years and Older.
  • Sexes Eligible for Study - All.

Inclusion Criteria:

  • Written informed consent before any assessment.
  • 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 course of 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.

    Other protocol-specified inclusion/exclusion criteria may apply 

Contacts:  Beachwood Office:  Dianne Himmelman 216-831-5700  dhimmelman@retina-assoc.com.  

To learn more: https://www.clinicaltrials.gov/ct2/show/NCT03481634