Initial observation or treatment for diabetic macular oedema with good visual acuity: two-year outcomes comparison in routine clinical practice: data from the Fight Retinal Blindness! Registry.

Pierre‐Henry Gabrielle,Vuong Nguyen,Samantha Fraser‐Bell,Hemal Mehta,Catherine Creuzot‐Garcher,Jennifer Arnold,Sanjeeb Bhandari,Mark Gillies,Francesco Viola,Daniel Barthelmes

doi:10.1111/aos.14672

Abstract

PurposeTo compare visual acuity (VA) change at 24 months in eyes with clinically significant DME (CSDME) and good VA initially treated versus initially observed in routine clinical practice.MethodsRetrospective analysis of treatment‐naïve eyes with CSDME and good VA (baseline VA ≥ 79 letters), with at least 24 months of follow‐up and initially managed with treatment (intravitreal treatment and/or macular laser) or observation with possible treatment after 4 months that were tracked in a prospectively designed observational registry.ResultsWe identified 150 eligible eyes (98 initially observed, 52 initially treated) of 130 patients. The proportion of eyes with at least a 5‐letter VA loss at 24 months was not significantly different between the groups: 65% with initial observation and 42% with initial treatment (p = 0.39). However, initially observed eyes were more likely to have a 10‐letter VA loss at 24 months (OR = 4.6, p = 0.022). Most of eyes in the initial observation group received at least one treatment (an intravitreal injection in 66% and macular laser in 20%) during the 24‐month period.ConclusionsThe risk of 5 letters loss was similar between both management groups. However, initially observed eyes were more at risk of developing moderate visual loss and more than 80% of them required treatment over 24 months.

Highlights

Several treatments, such as macular laser photocoagulation, surgery, intravitreal injections of VEGF inhibitors or steroids, have been proven to be effective for diabetic macular oedema (DME; Mitchell et al 2011; Wells et al 2016; Iglicki et al 2018, 2019; Mello Filho et al 2019; Zur et al 2019)
Protocol V by DRCR.net was the first RCT to compare visual outcomes in centre-involving DME (CI-DME) with good visual acuity (≥79 letters read on a logarithm of the minimum angle of resolution [logMAR] VA chart, 20/25 Snellen equivalent) treated with prompt macular laser photocoagulation, prompt observation or prompt intravitreal aflibercept
Treatmentna€ıve eyes with clinically significant DME (CSDME; defined as DME meeting one of these criteria: oedema within 500 lm of the centre of the fovea or at least 1 disc area of swelling, any part of which is within disc diameter of the centre of fovea) with good VA and at least 24 months of follow-up were identified

Summary

Introduction

Several treatments, such as macular laser photocoagulation, surgery, intravitreal injections of VEGF inhibitors or steroids, have been proven to be effective for diabetic macular oedema (DME; Mitchell et al 2011; Wells et al 2016; Iglicki et al 2018, 2019; Mello Filho et al 2019; Zur et al 2019). Protocol V by DRCR.net was the first RCT to compare visual outcomes in centre-involving DME (CI-DME) with good visual acuity (≥79 letters read on a logarithm of the minimum angle of resolution [logMAR] VA chart, 20/25 Snellen equivalent) treated with prompt macular laser photocoagulation, prompt observation or prompt intravitreal aflibercept. It reported no significant difference in visual outcomes at two years among the three groups, suggesting that initially observed eyes may achieve similar outcomes to those of initially treated eyes with reduced risk of injection-related adverse events and better cost-effectiveness (Baker et al 2019). This study aimed to compare visual outcomes in these eyes 24 months after they had either received initial treatment versus initial observation with treatment possible after the first 4 months in routine clinical practice

Objectives

Methods

Results

Discussion

Conclusion