Text Size: A A A      Contrast:       
 

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

Phase

Sponsor

Status

Diabetic Macular Edema

Drug:  Brolucizumab

Drug:  Aflibercept

Phase 3

Novartis

Enrolling

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