YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale.

Eter, Nicole; Singh, Rishi P; Abreu, Francis; Asik, Kemal; Basu, Karen; Baumal, Caroline; Chang, Andrew; Csaky, Karl G; Haskova, Zdenka; Lin, Hugh; Ruiz, Carlos Quezada; Ruamviboonsuk, Paisan; Silverman, David; Wykoff, Charles C; Willis, Jeffrey R.

Afiliação

Eter N; Department of Ophthalmology, University of Münster, Münster, Germany.
Singh RP; Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Abreu F; Genentech, Inc., South San Francisco, California.
Asik K; Genentech, Inc., South San Francisco, California.
Basu K; Roche Products (Ireland) Ltd., Dublin, Ireland.
Baumal C; New England Eye Center, Department of Ophthalmology, Tufts University School of Medicine, Boston, Massachusetts.
Chang A; Sydney Retina Clinic, Department of Clinical Ophthalmology & Eye Health, University of Sydney, Sydney Eye Hospital, Sydney, Australia.
Csaky KG; Retina Foundation of the Southwest, Dallas, Texas.
Haskova Z; Genentech, Inc., South San Francisco, California.
Lin H; Genentech, Inc., South San Francisco, California.
Ruiz CQ; Genentech, Inc., South San Francisco, California.
Ruamviboonsuk P; Clinica de Ojos Garza Viejo, San Pedro Garza Garcia, Mexico.
Silverman D; Department of Medical Policy Development and Strategic Planning, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.
Wykoff CC; Roche Products Ltd., Welwyn Garden City, United Kingdom.
Willis JR; Retina Consultants of Texas, Houston, Texas.

Ophthalmol Sci ; 2(1): 100111, 2022 Mar.

Article em En | MEDLINE | ID: mdl-36246184

Palavras-chave

AE, adverse event; Adjustable dosing; Angiopoietin-2; Antivascular endothelial growth factor; BCVA, best-corrected visual acuity; Bispecific antibody; CFP, color fundus photography; CRC, central reading center; CST, central subfield thickness; DME, diabetic macular edema; DR, diabetic retinopathy; Diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; FFA, fundus fluorescein angiography; Faricimab; ITT, intention-to-treat; IxRS, interactive voice or web-based response system; PRN, pro re nata; PTI, personalized treatment interval; Personalized treatment interval; Phase 3 clinical trial design; SD, spectral-domain; T&E, treat-and-extend; VEGF, vascular endothelial growth factor

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2022 Tipo de documento: Article