Status:
COMPLETED
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 t...
Detailed Description
Subjects in the United States who had completed the 96 week core trial, CRTH258A2301 (also referred as CRTH258-C002), were eligible to participate in the extension trial provided the core trial Visit ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2018
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03386474
Start Date
January 15 2018
End Date
September 6 2018
Last Update
January 5 2021
Active Locations (65)
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1
Novartis Investigative Site
Peoria, Arizona, United States, 85381
2
Novartis Investigative Site
Phoenix, Arizona, United States, 85014
3
Novartis Investigative Site
Arcadia, California, United States, 91006
4
Novartis Investigative Site
Huntington Beach, California, United States, 92647