TY - JOUR
T1 - SCORE2 Report 13
T2 - Intraretinal Hemorrhage Changes in Eyes With Central or Hemiretinal Vein Occlusion Managed With Aflibercept, Bevacizumab or Observation. Secondary Analysis of the SCORE and SCORE2 Clinical Trials
AU - SCORE2 Investigator Group
AU - Hendrick, Andrew
AU - VanVeldhuisen, Paul C.
AU - Scott, Ingrid U.
AU - King, Jacquie
AU - Blodi, Barbara A.
AU - Ip, Michael S.
AU - Khurana, Rahul N.
AU - Oden, Neal L.
N1 - Funding Information:
All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Funding/Support: This Study was supported by the National Eye Institute, National Institutes of Health , Department of Health and Human Services) grants U10EY023529 , U10EY023533 , and U10EY023521 . Support was 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. Author Contributions: A.H.: Conceptualization, investigation, review, and editing. P.C.V.: Data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, original draft, review, and editing. I.U.S.: Funding acquisition, methodology, project administration, resources, supervision, original draft, review, and editing. J.K.: Data curation, formal analysis, validation, original draft, review, and editing. B.A.B.: Funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, original draft, review, and editing. M.S.I.: Methodology, project administration, supervision, original draft, review, and editing. R.N.K.: Investigation, review, and editing. N.L.O.: Data curation, formal analysis, validation, original draft, review, editing. Financial Disclosures: I.U.S. served on the Data and Safety Monitoring Committee and Safety Review Committee for clinical trials sponsored by Novartis. M.S.I. is the consultant for Boehringer Ingelheim, Thrombogenics, Quark, Omeros, Allergan, Amgen, Astellas, and Alimera; and received honorarium for research support for Novartis, Genentech, Clearside, and Biogen. R.N.K. is the consultant for Allergan, Apellis, Bausch + Lomb, Genentech, Merck, and Regeneron; and received grant support from Allergan, Apellis, Chengdu Kanghong, Clearside Biomedical, Roche, and Santen. The other authors indicate no conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship.
Funding Information:
All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Funding/Support: This Study was supported by the National Eye Institute, National Institutes of Health, Department of Health and Human Services) grants U10EY023529, U10EY023533, and U10EY023521. Support was 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. Author Contributions: A.H.: Conceptualization, investigation, review, and editing. P.C.V.: Data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, original draft, review, and editing. I.U.S.: Funding acquisition, methodology, project administration, resources, supervision, original draft, review, and editing. J.K.: Data curation, formal analysis, validation, original draft, review, and editing. B.A.B.: Funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, original draft, review, and editing. M.S.I.: Methodology, project administration, supervision, original draft, review, and editing. R.N.K.: Investigation, review, and editing. N.L.O.: Data curation, formal analysis, validation, original draft, review, editing. Financial Disclosures: I.U.S. served on the Data and Safety Monitoring Committee and Safety Review Committee for clinical trials sponsored by Novartis. M.S.I. is the consultant for Boehringer Ingelheim, Thrombogenics, Quark, Omeros, Allergan, Amgen, Astellas, and Alimera; and received honorarium for research support for Novartis, Genentech, Clearside, and Biogen. R.N.K. is the consultant for Allergan, Apellis, Bausch + Lomb, Genentech, Merck, and Regeneron; and received grant support from Allergan, Apellis, Chengdu Kanghong, Clearside Biomedical, Roche, and Santen. The other authors indicate no conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2021/2
Y1 - 2021/2
N2 - Purpose: To investigate the relationship between intraretinal macular hemorrhage and visual acuity outcomes in eyes with central retinal vein occlusion or hemiretinal vein occlusion managed with aflibercept, bevacizumab, or observation. Design: Retrospective analysis of data from 2 randomized clinical trials. Methods: A total of 362 participants were randomized in the Study of Comparative Treatments for Retinal Vein Occlusion 2, and 88 participants randomized to observation in the Standard Care vs Corticosteroid in Retinal Vein Occlusion Study. Participants received monthly intravitreal aflibercept or bevacizumab through month 6 or observation through month 8. The main outcome was visual acuity letter score (VALS). Results: Reduced area of hemorrhage by month 6 was observed in 70.7% (116 of 164) of aflibercept-treated eyes, 63.8% (104 of 163) of bevacizumab-treated eyes, and 42.2% (27 of 64) of observation eyes by month 8 (P < .01). Relative to eyes with hemorrhage during follow-up, aflibercept-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 8.0 (99% confidence interval [CI]: 1.9, 14.2); bevacizumab-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 3.2 (99% CI: −4.6, 11.0); and observation eyes without hemorrhage at month 8 had a mean VALS improvement of 13.5 (99% CI: 0.4, 26.5). At month 6, the presence of hemorrhage and the change in central subfield thickness (CST) were significantly associated with the change in VALS; however, CST was a more important predictor. Conclusion: Improvement in hemorrhage during follow-up was associated with visual acuity improvements and predicted visual acuity changes beyond what was explained by CST. These findings suggest that intraretinal macular hemorrhage is an important indicator of disease severity in retinal vein occlusion.
AB - Purpose: To investigate the relationship between intraretinal macular hemorrhage and visual acuity outcomes in eyes with central retinal vein occlusion or hemiretinal vein occlusion managed with aflibercept, bevacizumab, or observation. Design: Retrospective analysis of data from 2 randomized clinical trials. Methods: A total of 362 participants were randomized in the Study of Comparative Treatments for Retinal Vein Occlusion 2, and 88 participants randomized to observation in the Standard Care vs Corticosteroid in Retinal Vein Occlusion Study. Participants received monthly intravitreal aflibercept or bevacizumab through month 6 or observation through month 8. The main outcome was visual acuity letter score (VALS). Results: Reduced area of hemorrhage by month 6 was observed in 70.7% (116 of 164) of aflibercept-treated eyes, 63.8% (104 of 163) of bevacizumab-treated eyes, and 42.2% (27 of 64) of observation eyes by month 8 (P < .01). Relative to eyes with hemorrhage during follow-up, aflibercept-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 8.0 (99% confidence interval [CI]: 1.9, 14.2); bevacizumab-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 3.2 (99% CI: −4.6, 11.0); and observation eyes without hemorrhage at month 8 had a mean VALS improvement of 13.5 (99% CI: 0.4, 26.5). At month 6, the presence of hemorrhage and the change in central subfield thickness (CST) were significantly associated with the change in VALS; however, CST was a more important predictor. Conclusion: Improvement in hemorrhage during follow-up was associated with visual acuity improvements and predicted visual acuity changes beyond what was explained by CST. These findings suggest that intraretinal macular hemorrhage is an important indicator of disease severity in retinal vein occlusion.
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U2 - 10.1016/j.ajo.2020.08.030
DO - 10.1016/j.ajo.2020.08.030
M3 - Article
C2 - 32828880
AN - SCOPUS:85096393439
SN - 0002-9394
VL - 222
SP - 185
EP - 193
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -