Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brolucizumab 3 mg
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
  • Drug: Brolucizumab
    Intravitreal injection
    Other names:
    • RTH258, ESBA1008
Experimental
Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
  • Drug: Brolucizumab
    Intravitreal injection
    Other names:
    • RTH258, ESBA1008
Active Comparator
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
  • Drug: Aflibercept
    Intravitreal injection
    Other names:
    • Eylea

Recruiting Locations

Novartis Investigative Site
Nashville, Tennessee 37232

More Details

NCT ID
NCT03481634
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.