Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 2/20/2019 |
Start Date: | January 15, 2018 |
End Date: | September 6, 2018 |
A 24-week, Double-masked, Multicenter, Two-arm Extension Study to Collect Safety and Efficacy Data on Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2301 Study
The purpose of this study is to collect data on safety and efficacy of the brolucizumab 6 mg
drug product intended for commercialization in patients with neovascular age-related macular
degeneration (nAMD) and to support comparability to the 6 mg drug product used in Phase III.
drug product intended for commercialization in patients with neovascular age-related macular
degeneration (nAMD) and to support comparability to the 6 mg drug product used in Phase III.
Inclusion Criteria:
- Sign written informed consent
- Completed the core study, CRTH258A2301
Exclusion Criteria:
- 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
- Other protocol-specified exclusion criteria may apply
We found this trial at
60
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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