Abstract
Purpose :
To assess the relationship between baseline factors and DME resolution in patients randomized to dexamethasone (DEX) intravitreal implant or sham treatment in the MEAD study.
Methods :
Of 1048 patients in MEAD full analysis set, this analysis included 351 patients treated with DEX 0.7 mg (given initially and up to q6 months based on eligibility criteria) and 350 patients treated with sham injection; 347 patients treated with DEX 0.35 mg were excluded. Effect of baseline factors (age, gender, ethnicity, diabetes type, HgbA1c, best-corrected visual acuity [BCVA]), central retinal thickness (CRT), DME onset and prior treatment, retina perfusion, and DRSS) on time to first DME resolution (CRT< 250 µm on time-domain OCT) were assessed in univariate and multivariate models and further evaluated by Kaplan-Meier methods based on tertiles of baseline factors.
Results :
DEX patients had a 2.1-fold higher rate of DME resolution, with median (95% confidence interval [CI]) time of 9 .0 (8.5, 9.3) months vs 26.8 (21.2, 29.5) months with sham (p<0.0001). Based on multivariate analysis of baseline factors, lower DME resolution rate in the sham group was associated with thicker CRT (OR [95%CI]: 1.00[0.99,1.00]; p<0.001). Lower DME resolution rate in the DEX group was associated with increased age (OR [95%CI]: 0.96[0.93,1.00]; p=0.042), thicker CRT (OR [95%CI]: 1.00[0.99,1.00]; p=0.001), and better BCVA (OR [95%CI]: 0.96[0.93,0.99]; p=0.013). Based on Kaplan-Meier analysis, tertiles of increasing CRT were associated with significantly longer median time to DME resolution and lower cumulative incidence of DME resolution in the sham group (median 15.2, 26.8, and 32.2 months for T1-T3, respectively) as compared to the DEX group (median 3.2, 9.2, and 14.9 months for T1-T3, respectively; HR of 1.9, 2.2, and 2.6 for T1-T3, respectively; all p<0.0001).
Conclusions :
Thicker CRT but also, perhaps paradoxically, better BCVA in the DEX group were baseline factors associated with lower rate of DME resolution in MEAD. These findings may inform physicians and patients regarding expectations of DME therapy.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.