Session Title: Vascular Diseases and Diabetic Retinopathy
Session Date/Time: Friday 18/09/2015 | 11:00-12:30
Paper Time: 11:48
First Author: : B.Gerendas AUSTRIA
Co Author(s): : C. Simader G. Deak M. Kundi S. Waldstein U. SchmidtErfurth
PURPOSE:To investigate the impact of the configuration of the vitreomacular interface evaluated on optical coherence tomography (OCT) on therapeutic outcomes of ranibizumab therapy, laser therapy and combined therapy for diabetic macular edema (DME).
In a post-hoc analysis, OCT data of 345 patients with DME enrolled in the 12-month RESTORE trial were evaluated at the Vienna Reading Center. All patients were randomized to one of three therapy arms: ranibizumab monotherapy (RBZ), combined ranibizumab plus laser therapy (COMB) and laser therapy only (LAS).
Monthly data of each patient was graded for the vitreomacular interface status by an experienced grader of the Vienna Reading Center. Grading categories were “complete adherence of vitreous”, “partial vitreomacular adhesion”, “vitreomacular traction”, and “complete posterior vitreous detachment”. From these categories at each visit, patients were divided into the following groups defining their status throughout the entire study: “complete vitreomacular adhesion”, “partial vitreomacular adhesion”, “change within the study”, “posterior vitreous detachment”. Retinal morphologic data (e.g. incidence of cysts or subretinal fluid, central retinal thickness) and functional outcomes (best corrected visual acuity (BCVA) at baseline and change from baseline to month 12) were compared between the vitreomacular interface groups. All analyses were performed separately for each therapy arm of the study.
Mean BCVA change from baseline to month 12 was (in letters, 95% confidence intervals, therapy arm, number of patients) for “complete vitreomacular adhesion” +10,4 (+7,1; +13,7; RBZ, n=36), +10,5 (+6,3; +14,7; COMB, n=21) and -3,3 (-7,3; +0,7; LAS, n=27); for “partial vitreomacular adhesion” +5,8 (+2,4; +9,3; RBZ, n=33), +7,9 (+4,9; +10,8; COMB, n=43) and +0,9 (-2,4; +4,0; LAS, n=37); for “change within the study” +7,4 (-0,8; +15,6; RBZ, n=6), +8,9 (+3,1; +14,7; COMB, n=12) and +6,4 (-0,5; +13,3; LAS, n=9); and for “posterior vitreous detachment” +6,4 (+2,9; +9,9; RBZ, n=31), +5,3 (+1,6; +8,9; COMB, n=31) and +3,0 (-0,8; +6,7; LAS, n=30). Decrease of central retinal thickness from baseline to month 12 corresponded to the BCVA gains. In a pooled analysis of all treatment arms, eyes with “complete vitreomacular adhesion” showed 66 letters of BCVA score at baseline and 73 letters at month 12, while the 'posterior vitreous detachment' and the 'partial vitreomacular adhesion' groups demonstrated 62 letters at baseline and 65 (66) letters at month 12.
The status of the vitreomacular interface has substantial impact on functional outcomes in the therapy of DME. Most importantly and similarly to other indications such as neovascular age-related macular degeneration, the vitreomacular interface configuration appears to influence the efficacy of different treatment regimens. Patients with 'posterior vitreous detachment' showed similar BCVA benefits independent of treatment modality. In contrast, patients with 'complete vitreomacular adhesion' afforded excellent BCVA gains with ranibizumab therapy and combined therapy with ranibizumab and laser, while laser monotherapy resulted in loss of visual function. Our study provides evidence for the critical role of the vitreomacular interface configuration in antiangiogenic therapy across diseases and indications.