Original ArticleHAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration
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Disclosure(s): All authors have completed and submitted the ICMJE disclosures form.
The author(s) have made the following disclosure(s): P.U.D.: Consultant – Bausch & Lomb Pharma, Genentech, Alcon Surgical, Alcon Pharmaceutical, NeoVista, MacuSight, ArticDx, ORA, Novartis, Allergan, Santen, Inc., Thrombogenics, Ophthotech, Lux BioScience, DigiSight, Roche, TopCon, Acucela, Pentavision, ORA, Stealth Biotherapeutics, Annidis, Clearside Biomedical, Optovue, Pentavision, Neurotech, Lutronic, Alimera Sciences, DOSE Medical, Aerpio, Omeros, Shire Human Genetics, Opthea, Spark Thereapeutics, Graybug Vision, Zeiss Group, Irenix, ByeOnics, Clearside Biomedical, PanOptica, Chengdu Kanghong Biotechnology, SciFluor Life Sciences, Boehringer Ingelheim, Kodiak Sciences Oculis SA, pSivida Corporation Amgen, Aerie Pharmaceutical; Scientific advisory board – Alcon Surgical (RACII), Genentech, MacuSight, Novartis, NeoVista, ArticDX, Alcon Pharmaceutical, AMO, Thrombogenics, Santen, Ophthotech, Lux BioScience, Digisight, Roche, Acucela, Stealth Biotherapeutics, Lutronic, Avalanche, TrueVision, Alimera Sciences, Orbis International, Annidis, Neurotech, Aerpio, DOSE Medical, Omeros, Shire Human Genetics, Opthea, Graybug Vision, CDR-Life, Inc., Clearside Biomedical; Equity owner – Alimera Sciences, Aerpio, Annidis, ArctixDx, Digisight, Irenix, Ophthotech, Clearside Biomedical, PanOptica
R.P.S.: Consultant – Novartis, Genentech/Roche, Alcon, Regeneron, Bayer, Optos, Genentech; Financial support – Apellis
A.K.: Consultant – Novartis, Bayer, Allergan, Carl Zeiss Meditec, Heidelberg Engineering
Y.O.: Financial support – Novartis Pharma, Bayer, Senju, Kowa, Wakamoto, Hoya, Santen
G.W.: Employee – Novartis Pharmaceuticals
K.G.: Employee – Novartis Pharmaceuticals
G.J.J.: Financial support – Alcon/Novartis, Sanofi, Heidelberg Engineering, Novartis, pSivida, Regeneron
R.T.: Consultant – Alcon, Allergan, B+L, Bayer, FCI, Genentech, Novartis, Roche, Thea, Thrombogenics, Zeiss
U.S.-E.: Financial support – Novartis, Genentech, Novartis, Boehringer, Roche
F.G.H.: Consultant – Heidelberg Engineering, Zeiss, Acucela, Genentech/Roche, Allergan, Boehringer-Ingelheim, Bayer Healthcare, LIN Bioscience, Pixium, Chengdu Kanghong; Financial support – Novartis, Nightstar, Optos, Heidelberg Engineering, Carl Zeiss Meditec, Allergan, Roche/Genentech, Pixium; Lecturer – Roche/Genentech, Zeiss, Heidelberg Engineering, Bayer Healthcare.
Supported by Novartis Pharma AG, Basel, Switzerland. The sponsor or funding organization participated in the design of the study; management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
HUMAN SUBJECTS: Human subjects were included in this study. This multicenter trial was conducted in 408 sites in North, Central, and South America; Europe; Asia; Australia; and Japan. All patients provided written informed consent. Protocols were approved by an Independent Ethics Committee/Institutional Review Board. Trials were conducted in accordance with principles of the Declaration of Helsinki, International Conference on Harmonization E6 Good Clinical Practice Consolidated Guideline, and other regulations as applicable and were compliant with the Health Insurance Portability and Accountability Act of 1996. All patients provided written informed consent.
No animal subjects were included in this study.
Author Contributions:
Conception and design: Weissgerber
Analysis and interpretation: Dugel, Singh, Koh, Ogura, Weissgerber, Gedif, Jaffe, Tadayoni, Schmidt-Erfurth, Holz
Data collection: Dugel, Singh, Koh, Ogura, Weissgerber, Gedif, Jaffe, Tadayoni, Schmidt-Erfurth, Holz
Obtained funding: N/A
Overall responsibility: Dugel, Singh, Koh, Ogura, Weissgerber, Gedif, Jaffe, Tadayoni, Schmidt-Erfurth, Holz