Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections

Stopped early · Phase 3

Conditions studied: Age-Related Macular Degeneration

In brief

This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

Key facts

Study ID

NCT03710564

Run by

Novartis Pharmaceuticals

People needed

535

Starts

2018-10-30

Expected to finish

2021-07-01

Last updated by the study team

2023-01-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Diagnosis of wet age-related macular degeneration (AMD)
• Currently receiving anti-VEGF injections

You may not qualify if…

• Active infection or inflammation in either eye
• Significant fibrosis in the study eye
• Recent ocular surgery
• Uncontrolled glaucoma
• Use of medications as specified in the protocol
• Pregnant, nursing
• Of child-bearing potential unless using highly effective method of contraception

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Mountain View, California, United States
• Novartis Investigative Site — Oakland, California, United States
• Novartis Investigative Site — Oxnard, California, United States
• Novartis Investigative Site — Palo Alto, California, United States
• Novartis Investigative Site — Redlands, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Santa Barbara, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Golden, Colorado, United States
• Novartis Investigative Site — Deerfield Beach, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Mt. Dora, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Stuart, Florida, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — ‘Aiea, Hawaii, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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