Abstract
New clinical trials for diabetic macular oedema (DMO) are being designed to prove superiority over aflibercept when this agent is already very effective in improving visual acuity (VA) and DMO. The aim of this study was to determine the optimal inclusion–exclusion criteria for trials to aim for superiority in visual outcomes with newer agents. As Phase 1 studies are short duration, we aimed to evaluate the early response of aflibercept in a real-world cohort initiated on monthly aflibercept for 3 consecutive injections and observed the effects at 4 months. The sub-optimal responders were pre-defined based on different cut-offs for VA and central sub-field thickness (CST). 200 patients with treatment naïve DMO treated with 3 loading doses of aflibercept were included in the study. We found that those presenting with baseline VA of 35–54 ETDRS letters (n = 43) had higher proportion of sub-optimal responders compared to other categories (p < 0.001). Patients with baseline CST of less than 400 µm (n = 96) responded less well functionally and anatomically to loading dose than eyes with baseline CST of 400 µm or more (n = 104, p = 0.02), indicating that eyes with CST ≥ 400 µm is another inclusion criteria. There was minimal correlation between change in CST and change in VA at 4 months (r = − 0.27), suggesting that both these inclusion criteria are non-exclusive. However, for maximal efficacy, patients that meet both these inclusion criteria are more likely to show benefit from an alternative intervention. New trials should aim to include patients with treatment naïve DMO with VA between 35–54 letters and CST of 400 µm or more when aflibercept is used as the comparator.
Highlights
New clinical trials for diabetic macular oedema (DMO) are being designed to prove superiority over aflibercept when this agent is already very effective in improving visual acuity (VA) and DMO
Two hundred eyes that received intravitreal aflibercept loading doses for new onset DMO between December 2016 and September 2019 and had complete dataset were included in the analyses
This study evaluated early response of DMO to intravitreal aflibercept to decipher the baseline features of limited early responders so that newer drugs can be evaluated on a more appropriate patient cohort
Summary
New clinical trials for diabetic macular oedema (DMO) are being designed to prove superiority over aflibercept when this agent is already very effective in improving visual acuity (VA) and DMO. 200 patients with treatment naïve DMO treated with 3 loading doses of aflibercept were included in the study We found that those presenting with baseline VA of [35–54] ETDRS letters (n = 43) had higher proportion of sub-optimal responders compared to other categories (p < 0.001). VA responses at 12 weeks have been explored to assess long-term outcomes with conflicting results in trials of new agents aiming for superior visual outcomes[9,10]. It is clear from the trial design of Protocol U that there is always room for improvement in eyes with DMO when sub-optimally treated with anti-VEGF a gents[10]. In Protocol U, when treated with ranibizumab loading dose before randomisation approximately 45% of the patients defined as having persistent oedema improved, suggesting that most eyes assumed to have persistent oedema respond to anti-VEGF agent when optimally treated
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