Early Residual Fluid-Free Status and Long-Term BCVA Outcomes: A Treatment Agnostic, Post Hoc Analysis of Pooled HAWK and HARRIER Data.
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Version: Final published version
License: CC BY-NC-ND 4.0
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_86FF33B95ED1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Early Residual Fluid-Free Status and Long-Term BCVA Outcomes: A Treatment Agnostic, Post Hoc Analysis of Pooled HAWK and HARRIER Data.
Journal
American journal of ophthalmology
ISSN
1879-1891 (Electronic)
ISSN-L
0002-9394
Publication state
Published
Issued date
04/2022
Peer-reviewed
Oui
Volume
236
Pages
12-19
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
The aim of this study was to determine associations between early residual fluid (ERF)-free status and improved long-term visual outcomes.
This was a retrospective clinical cohort study from a post hoc analysis of 2 phase III clinical trials' data.
Independent of treatment allocation, patients from the multicenter, prospective, randomized, double-masked HAWK and HARRIER trials who received either brolucizumab 6 mg or aflibercept 2 mg were split into 2 cohorts depending on the presence or absence of ERF at week 12. In addition, similar analyses were performed on the presence or absence of early residual intraretinal fluid (IRF) and subretinal fluid (SRF) at week 12. The 2 groups, ERF-free (n = 1051) and ERF (n = 366) patients were compared. Changes from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST) were determined.
From week 12 to 96, patients who were ERF free had greater least squares (LS) mean increases from baseline for BCVA and CST compared to ERF patients. Greater LS mean differences in BCVA from week 12 to 96 were noted between ERF-free and ERF patients. A greater proportion of patients in the ERF-free cohort reported a ≥5, ≥10, or ≥15 letter improvement, and a higher proportion reported BCVA ≥70 letters from baseline to week 96 compared to patients with fluid.
Improvements in visual outcomes in ERF-free patients were greater than in ERF patients occurring as early as 4 weeks (week 12) after the last loading dose and continued to week 96. Therefore, ERF status may be a useful indicator of anti-vascular endothelial growth factor treatment response.
This was a retrospective clinical cohort study from a post hoc analysis of 2 phase III clinical trials' data.
Independent of treatment allocation, patients from the multicenter, prospective, randomized, double-masked HAWK and HARRIER trials who received either brolucizumab 6 mg or aflibercept 2 mg were split into 2 cohorts depending on the presence or absence of ERF at week 12. In addition, similar analyses were performed on the presence or absence of early residual intraretinal fluid (IRF) and subretinal fluid (SRF) at week 12. The 2 groups, ERF-free (n = 1051) and ERF (n = 366) patients were compared. Changes from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST) were determined.
From week 12 to 96, patients who were ERF free had greater least squares (LS) mean increases from baseline for BCVA and CST compared to ERF patients. Greater LS mean differences in BCVA from week 12 to 96 were noted between ERF-free and ERF patients. A greater proportion of patients in the ERF-free cohort reported a ≥5, ≥10, or ≥15 letter improvement, and a higher proportion reported BCVA ≥70 letters from baseline to week 96 compared to patients with fluid.
Improvements in visual outcomes in ERF-free patients were greater than in ERF patients occurring as early as 4 weeks (week 12) after the last loading dose and continued to week 96. Therefore, ERF status may be a useful indicator of anti-vascular endothelial growth factor treatment response.
Keywords
Angiogenesis Inhibitors/therapeutic use, Clinical Trials, Phase III as Topic, Cohort Studies, Humans, Intravitreal Injections, Multicenter Studies as Topic, Prospective Studies, Randomized Controlled Trials as Topic, Ranibizumab/therapeutic use, Receptors, Vascular Endothelial Growth Factor/therapeutic use, Retrospective Studies, Tomography, Optical Coherence, Treatment Outcome, Vascular Endothelial Growth Factor A, Visual Acuity
Pubmed
Web of science
Open Access
Yes
Create date
06/11/2021 18:00
Last modification date
27/08/2024 7:27