The COED trial prospectively compared a dexamethasone implant plus aflibercept against aflibercept monotherapy for diabetic macular oedema.
Vision and anatomy were similar at 48 weeks — the difference in central subfield thickness (-32.9 µm) and in visual acuity (-3.3 letters) both favoured combination but neither was significant. What differed was burden and safety: the combination resolved oedema a median of 12 weeks sooner (log-rank p=0.013) and needed about one fewer injection over the study (4.9 versus 5.9), but caused more cataract progression and raised intraocular pressure requiring treatment.
This is not a reason to add a steroid implant routinely. It is a considered option for a pseudophakic eye where reducing injection frequency matters and the intraocular-pressure risk is acceptable and monitorable. In a phakic eye, the cataract cost usually outweighs the injection saving.
- Similar vision and anatomy to aflibercept alone at 48 weeks
- Oedema resolved a median 12 weeks sooner; about one fewer injection
- More cataract progression and raised intraocular pressure with the implant
- Best considered in pseudophakic eyes where injection burden is the problem
The statistics, in plain English
The visual and thickness differences were not statistically significant, meaning the trial could not show the combination improves the outcomes patients care about most — it changed how fast and how often, not how well. The injection-rate ratio of 1.9 (95% CI 0.9 to 4.0) crosses 1.0, so even the injection-sparing benefit is statistically uncertain in this small trial.
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