Novartis KESTREL for Diabetic Macular Edema Study

Active Clinical Trials // Jan 28 2019

Clinical Trial Protocol [CRTH258B2301] (KESTREL)

Sponsor: Novartis Pharmaceuticals

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

Brief Summary:

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).

Detailed Description:

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.

Current Primary Outcome Measures:

Change from baseline in best-corrected visual acuity (BCVA) at Week 52  Time Frame: Baseline, Week 52

Intervention

  • Drug: Brolucizumab

Intravitreal injection

Other Name: RTH258, ESBA1008

  • Drug: Aflibercept

Intravitreal injection

Other Name: Eylea

Study Arms

  • Experimental: Brolucizumab 3 mg

Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule

Intervention: Drug: Brolucizumab

  • Experimental: Brolucizumab 6 mg

Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule

Intervention: Drug: Brolucizumab

  • Active Comparator: Aflibercept 2 mg

Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks

Intervention: Drug: Aflibercept

Eligibility Criteria:

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.

Ages 18 years and older

For more information please contact Angie Adler 608 265-7557