Editorial

. 2023 Oct;37(15):3059-3060.

doi: 10.1038/s41433-023-02465-4. Epub 2023 Mar 3.

Noninferiority randomised trials in ophthalmology

Collaborators, Affiliations

Collaborators

Retina Evidence and Trials INternational Alliance (R.E.T.I.N.A.) Study Group:
Sobha Sivaprasad, Peter Kaiser, David Sarraf, Sophie J Bakri, Rishi P Singh, Frank G Holz, Tien Y Wong

Affiliations

¹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
² Population Health Research Institute, Hamilton, ON, Canada.
³ Division of Internal Medicine, McMaster University, Hamilton, ON, Canada.
⁴ Retina Consultants of Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.
⁵ Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, PA, USA.
⁶ Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia.
⁷ Department of Surgery (Ophthalmology), The University of Melbourne, Melbourne, VIC, Australia.
⁸ Biostatistics Unit, St. Joseph's Healthcare-Hamilton, Hamilton, ON, Canada.
⁹ Department of Surgery, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.
¹¹ Department of Surgery, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.

^# Contributed equally.

PMID: 36869135
PMCID: PMC10564920
DOI: 10.1038/s41433-023-02465-4

Editorial

Noninferiority randomised trials in ophthalmology

Kevin Kim et al. Eye (Lond). 2023 Oct.

. 2023 Oct;37(15):3059-3060.

doi: 10.1038/s41433-023-02465-4. Epub 2023 Mar 3.

Authors

Collaborators

Retina Evidence and Trials INternational Alliance (R.E.T.I.N.A.) Study Group:
Sobha Sivaprasad, Peter Kaiser, David Sarraf, Sophie J Bakri, Rishi P Singh, Frank G Holz, Tien Y Wong

Affiliations

¹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
² Population Health Research Institute, Hamilton, ON, Canada.
³ Division of Internal Medicine, McMaster University, Hamilton, ON, Canada.
⁴ Retina Consultants of Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.
⁵ Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, PA, USA.
⁶ Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia.
⁷ Department of Surgery (Ophthalmology), The University of Melbourne, Melbourne, VIC, Australia.
⁸ Biostatistics Unit, St. Joseph's Healthcare-Hamilton, Hamilton, ON, Canada.
⁹ Department of Surgery, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.
¹¹ Department of Surgery, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.

^# Contributed equally.

PMID: 36869135
PMCID: PMC10564920
DOI: 10.1038/s41433-023-02465-4

No abstract available

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Fig. 1. Illustration of Possible Outcome Scenarios in Non-Inferiority Trials.**
Listed possible outcome scenarios in non-inferiority trials (A–E) interpreted based on the “line of no difference” and the noninferiority margin.

See this image and copyright information in PMC

Comment on

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials.
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Heier JS, et al. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24. Lancet. 2022. PMID: 35085502 Clinical Trial.

References

1. ICH. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human (ICH) Use Topic E 10—choice of control group in clinical trials. 2001;1999. 10.1299/kikaic.61.4696
1. US Food and Drug Administration, CDER. Non-inferiority clinical trials to establish effectiveness guidance for industry. 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
1. Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399:729–40. doi: 10.1016/S0140-6736(22)00010-1. - DOI - PubMed
1. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31. doi: 10.1056/NEJMoa054481. - DOI - PubMed
1. Coassin M, De Maria M, Mastrofilippo V, Braglia L, Cimino L, Sartori A, et al. Anterior chamber inflammation after cataract surgery: a randomized clinical trial comparing bromfenac 0.09% to dexamethasone 0.1% Adv Ther. 2019;36:2712–22. doi: 10.1007/s12325-019-01076-4. - DOI - PubMed

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Noninferiority randomised trials in ophthalmology

Collaborators

Affiliations

Noninferiority randomised trials in ophthalmology

Authors

Collaborators

Affiliations

Conflict of interest statement

Figures

Comment on

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical