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

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

Key facts

Study ID

NCT03481634

Run by

Novartis Pharmaceuticals

People needed

566

Starts

2018-07-23

Expected to finish

2021-10-18

Last updated by the study team

2023-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — La Jolla, California, United States
• Novartis Investigative Site — Mountain View, California, United States
• Novartis Investigative Site — Santa Barbara, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Danbury, Connecticut, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Stuart, Florida, United States
• Novartis Investigative Site — ‘Aiea, Hawaii, United States
• Novartis Investigative Site — Urbana, Illinois, United States
• Novartis Investigative Site — Wheaton, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — New Albany, Indiana, United States
• Novartis Investigative Site — Leawood, Kansas, United States
• Novartis Investigative Site — Lenexa, Kansas, United States
• Novartis Investigative Site — Paducah, Kentucky, United States
• Novartis Investigative Site — Springfield, Massachusetts, United States
• Novartis Investigative Site — Stoneham, Massachusetts, United States
• Novartis Investigative Site — Reno, Nevada, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Kingston, Pennsylvania, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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