Visual acuity time in range: a novel concept to describe consistency in treatment response in diabetic macular oedema.

Kozak, Igor ORCID: 0000-0003-1813-0017, Pearce, Ian, Cheung, Chui Ming Gemmy ORCID: 0000-0003-3358-3516, Machewitz, Tobias, Lambrou, George N, Molina, Daniel, Suleiman, Lima, Youssef, Hossam and Bressler, Neil M (2023) Visual acuity time in range: a novel concept to describe consistency in treatment response in diabetic macular oedema. Eye (London, England), 37 (16). pp. 3367-3375.

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Abstract

<h4>Objective</h4>To assess 'time in range' as a novel measure of treatment response in diabetic macular oedema (DMO).<h4>Methods</h4>This post hoc analysis of the Protocol T randomised clinical trial included 660 individuals with centre-involved DMO and best-corrected visual acuity (BCVA) letter score ≤78-≥24 (approximate Snellen equivalent 20/32-20/320). Study participants received intravitreal aflibercept 2.0 mg, repackaged (compounded) bevacizumab 1.25 mg, or ranibizumab 0.3 mg given up to every 4 weeks using defined retreatment criteria. Mean time in range was calculated using a BCVA letter score threshold of ≥69 (20/40 or better; minimum driving requirement in many regions), with sensitivity analyses using BCVA thresholds from 100 to 0 (20/10 to 20/800) in 1-letter increments.<h4>Results</h4>Time in range was defined as either the absolute or relative duration above a predefined BCVA threshold, measured in weeks or as a percentage of time, respectively. Using a BCVA letter score threshold of ≥69 (20/40 or better), the least squares mean time in range (adjusted for baseline BCVA) in Year 1 was 41.2 weeks with intravitreal aflibercept, 4.0 weeks longer (95% CI: 1.7, 6.3; p = 0.002) than bevacizumab and 3.6 weeks longer (1.3, 5.9; p = 0.004) than ranibizumab. Overall, mean time in range was numerically longer for intravitreal aflibercept for all BCVA letter score thresholds between 92 and 30 (20/20 to 20/250). In the Day 365-728 analysis, time in range was 3.9 (1.3, 6.5) and 2.4 (0.0, 4.9) weeks longer with intravitreal aflibercept vs bevacizumab and vs ranibizumab (p = 0.011 and 0.106), respectively.<h4>Conclusion</h4>BCVA time in range may represent another way to describe visual outcomes and potential impact on vision-related functions over time for patients with DMO and provide a better understanding, for physicians and patients, of the consistency of treatment efficacy.

Item Type:	Article
Uncontrolled Keywords:	Humans, Diabetic Retinopathy, Diabetes Mellitus, Receptors, Vascular Endothelial Growth Factor, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Visual Acuity, Macular Edema, Intravitreal Injections, Bevacizumab, Ranibizumab
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User:	Symplectic Admin
Date Deposited:	19 May 2023 10:15
Last Modified:	03 Feb 2024 03:06
DOI:	10.1038/s41433-023-02507-x
Open Access URL:	https://doi.org/10.1038/s41433-023-02507-x
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3170540