Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

Completed · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).

Key facts

Study ID

NCT03386474

Run by

Novartis Pharmaceuticals

People needed

151

Starts

2018-01-15

Expected to finish

2018-09-06

Last updated by the study team

2021-01-05

Who can join

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

You may qualify if…

• Sign written informed consent
• Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.

You may not qualify if…

• Patient discontinued the treatment or the core study prematurely at any time
• Patient received standard of care treatment for nAMD after completion of the core study
• Pregnant or nursing women and women of child-bearing potential
• Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Arcadia, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — La Jolla, California, United States
• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Mountain View, California, United States
• Novartis Investigative Site — Oakland, California, United States
• Novartis Investigative Site — Redlands, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Golden, Colorado, United States
• Novartis Investigative Site — Bridgeport, Connecticut, United States
• Novartis Investigative Site — New London, Connecticut, United States
• Novartis Investigative Site — Altamonte Springs, Florida, United States
• Novartis Investigative Site — Deerfield Beach, Florida, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Palm Beach Gardens, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Vero Beach, Florida, United States
• Novartis Investigative Site — Winter Haven, Florida, United States
• Novartis Investigative Site — Boise, Idaho, United States
• Novartis Investigative Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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