TY - JOUR
T1 - Association between early and late response in eyes with central or hemiretinal vein occlusion treated with anti-VEGF agents
T2 - SCORE2 report 12: secondary analysis of the SCORE2 clinical trial
AU - for the SCORE2 Investigator Group
AU - Khurana, Rahul N.
AU - Oden, Neal L.
AU - VanVeldhuisen, Paul C.
AU - Scott, Ingrid U.
AU - Blodi, Barbara A.
AU - Ip, Michael S.
N1 - Funding Information:
Ingrid U. Scott, M.D., M.P.H.: serves as Principal Investigator and Chair of SCORE2, which is funded by the National Eye Institute, and has served on the Data and Safety Monitoring Committee of clinical trials sponsored by Novartis (Basel, Switzerland).
Funding Information:
Neal L. Oden, Ph.D.: work supported by grant 1U10EY023529 from the National Eye Institute of the National Institutes of Health.
Funding Information:
The Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Investigator Group members are SCORE2 Executive Committee : Ingrid U. Scott, (Study Chair), Penn State College of Medicine; Michael S. Ip (Study Co-Chair), Doheny Eye Center UCLA; Barbara A. Blodi (Principal Investigator), Fundus Photograph Reading Center; Sangeeta Bhargava (Director, Clinical Trials), National Eye Institute, NIH; Paul VanVeldhuisen (DCC Principal Investigator), The Emmes Company, LLC; Neal L. Oden (DCC Statistician), The Emmes Company, LLC; Maria J. Figueroa (DCC Project Director), The Emmes Company, LLC. SCORE2 Data and Safety Monitoring Committee : David C. Musch (Chair), University of Michigan; Sangeeta Bhargava, National Eye Institute, NIH; Dennis P. Han, Medical College of Wisconsin; Srinivas R. Sadda, Doheny Eye Institute; George A. Williams, Beaumont Eye Institute; Stephen Wisniewski, University of Pittsburgh. Penn State University : Ingrid U. Scott (Study Chair), Janelle Gaston (Research Project Manager).
Funding Information:
Supported by the National Eye Institute (National Institutes of Health, Department of Health and Human Services) grants U10EY023529, U10EY023533, and U10EY023521. Support also provided in part by Regeneron, Inc. and Allergan, Inc. through donation of investigational drug. This work was supported in part by an unrestricted grant from Research to Prevent Blindness, Inc. to the University of Wisconsin Madison Department of Ophthalmology and Visual Sciences and to the Jules Stein Eye Institute and Doheny Eye Institute, Department of Ophthalmology at the University of California Los Angeles, CA.
Publisher Copyright:
© 2021, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2021/7
Y1 - 2021/7
N2 - Purpose: To assess whether early visual acuity letter score change from baseline (ΔVALS) and early spectral domain optical coherence tomography (SD-OCT) measures of center point thickness (CPT) are associated with later ΔVALS in eyes with macular edema due to central or hemiretinal vein occlusion treated with intravitreal aflibercept or bevacizumab. Methods: Secondary analysis of a randomized clinical trial of 362 participants. Results: Considered separately at month 3, CPT (categorized as ≤ 300 μm, > 300 μm) and ΔVALS (categorized as < 5, 5–9, ≥ 10) are predictive of ΔVALS at month 6 (aflibercept: P = 0.02 for CPT and P < 0.0001 for ΔVALS; bevacizumab: P = 0.007 for CPT and P < 0.0001 for ΔVALS) and, except for CPT in the bevacizumab arm, also predictive of ΔVALS at month 12 (aflibercept: P = 0.03 for CPT and P < 0.0001 for ΔVALS; bevacizumab: P = 0.18 for CPT and P < 0.0001 for ΔVALS). Month 3 predictors are also associated with average ΔVALS from months 4 to 12 (CPT P = 0.01 in the aflibercept arm, P = 0.02 in the bevacizumab arm; ΔVALS > 10 versus < 5; P < 0.001 for both aflibercept and bevacizumab). When month 3 measures are considered jointly, ΔVALS effect remains significant for average ΔVALS from months 4 to 12 (aflibercept: P = 0.002; bevacizumab: P < 0.0001) but not CPT (aflibercept: P = 0.18; bevacizumab: P = 0.22). Conclusion: While both month 3 ΔVALS and CPT are predictive of ΔVALS after month 3 through month 12, early ΔVALS has a stronger relationship than CPT with later ΔVALS. SCORE2 registration number is NCT01969708. [Figure not available: see fulltext.]
AB - Purpose: To assess whether early visual acuity letter score change from baseline (ΔVALS) and early spectral domain optical coherence tomography (SD-OCT) measures of center point thickness (CPT) are associated with later ΔVALS in eyes with macular edema due to central or hemiretinal vein occlusion treated with intravitreal aflibercept or bevacizumab. Methods: Secondary analysis of a randomized clinical trial of 362 participants. Results: Considered separately at month 3, CPT (categorized as ≤ 300 μm, > 300 μm) and ΔVALS (categorized as < 5, 5–9, ≥ 10) are predictive of ΔVALS at month 6 (aflibercept: P = 0.02 for CPT and P < 0.0001 for ΔVALS; bevacizumab: P = 0.007 for CPT and P < 0.0001 for ΔVALS) and, except for CPT in the bevacizumab arm, also predictive of ΔVALS at month 12 (aflibercept: P = 0.03 for CPT and P < 0.0001 for ΔVALS; bevacizumab: P = 0.18 for CPT and P < 0.0001 for ΔVALS). Month 3 predictors are also associated with average ΔVALS from months 4 to 12 (CPT P = 0.01 in the aflibercept arm, P = 0.02 in the bevacizumab arm; ΔVALS > 10 versus < 5; P < 0.001 for both aflibercept and bevacizumab). When month 3 measures are considered jointly, ΔVALS effect remains significant for average ΔVALS from months 4 to 12 (aflibercept: P = 0.002; bevacizumab: P < 0.0001) but not CPT (aflibercept: P = 0.18; bevacizumab: P = 0.22). Conclusion: While both month 3 ΔVALS and CPT are predictive of ΔVALS after month 3 through month 12, early ΔVALS has a stronger relationship than CPT with later ΔVALS. SCORE2 registration number is NCT01969708. [Figure not available: see fulltext.]
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U2 - 10.1007/s00417-020-05018-7
DO - 10.1007/s00417-020-05018-7
M3 - Article
C2 - 33415354
AN - SCOPUS:85098955742
SN - 0065-6100
VL - 259
SP - 1839
EP - 1851
JO - Albrecht von Graefes Archiv für Klinische und Experimentelle Ophthalmologie
JF - Albrecht von Graefes Archiv für Klinische und Experimentelle Ophthalmologie
IS - 7
ER -