GRAding of functional and anatomical response to DExamethasone implant in patients with Diabetic Macular Edema: GRADE-DME Study

Abstract

To analyze functional and anatomical response patterns to dexamethasone (DEX) implant in diabetic macular edema (DME), to describe proportion of responders and non-responders, and to propose a new DME grading system. Retrospective, multicenter, observational cohort study. Naive and non-naive DME patients were treated with DEX, with visual acuity (VA)>= 0.2 logMAR and central subfield thickness (CST) of >= 300 mu m. Functional and anatomical responses were graded after 2 and 4 months, and categorized as early and stable improvement, early and progressive improvement, pendular response, delayed improvement, and persistent non-response. 417 eyes were included (175 treatment naive eyes). Compared to non-naive eyes, naive eyes showed a very good functional response (VA gain >= 10 letters) more frequently after 2 and 4 months (56% and 57% [naive] vs. 33% and 28% [non-naive], p<0.001). A VA gain<5 letters (non-response) after 2 and 4 months was seen in 18% and 16% of naive eyes, and in 49% and 53% of non-naive eyes (p<0.001). A lack of anatomical response was rare in both groups, but more frequently in non-naive eyes (12% vs. 4%, p=0.003). Functionally and anatomically, naive eyes showed most frequently an early and stable improvement (functionally: 77/175 44%; anatomically: 123/175 eyes, 70%). Most non-naive eyes experienced no significant improvement functionally (97/242 eyes, 40%), despite a mostly early and stable improvement anatomical response pattern (102/242 eyes, 42%). Functional but not anatomical response patterns were influenced by baseline VA. Naive and non-naive eyes show different functional and anatomical response patterns to DEX implant. Functional non-responders are rare in naive eyes, whereas anatomical non-response is unusual in both groups.