Trial reportBMC ophthalmology2025
Baseline factors affecting diabetic macular oedema resolution after intravitreal dexamethasone implant treatment: post hoc analysis of the MEAD study.
Trial report in BMC ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Who cites it
0 citing papers in PubMed.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundConsidering evidence that some baseline clinical parameters correlate with diabetic macular oedema (DME) response to intravitreal anti-VEGF treatment and prognosis, investigation of baseline characteristics that could predict treatment response to dexamethasone intravitreal implant (DEX) and facilitate treatment selection was warranted. This study evaluated the relationship between baseline characteristics and time to first DME resolution in patients treated with DEX.
methodsThis post hoc analysis of the MEAD study (which consisted of 2 randomised, multicentre, masked, sham-controlled, phase 3 clinical trials identical in design) included 351 eyes treated with DEX 0.7 mg and 350 with sham over 3 years, with retreatment possible every ≥ 6 months if eligibility criteria were met. The effect of baseline characteristics on the time to first DME resolution (defined as central retinal/subfield thickness [CRT] < 250 μm) was evaluated with univariate and multivariate models, and further assessed with Kaplan-Meier method.
resultsThe median (95% CI) time to first DME resolution was 9.0 (8.5-9.3) months for the DEX group. The hazard ratio for DME resolution (DEX versus sham) was 2.09 (P < 0.0001). Higher CRT was associated with longer time to DME resolution.
conclusionsTreatment with DEX shortened the time to DME resolution compared with sham. Higher CRT was associated with longer time to DME resolution. These findings may influence therapeutic decisions.
trial registrationclinicaltrials.gov NCT00168337 and NCT00168389.
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