Anti-VEGF Monotherapy versus Combined Anti-VEGF and Endpoint Management Laser for Diabetic Macular Edema (END-DME Study)

초록

Purpose: To compare the efficacy of a combination of anti-vascular endothelial growth factor (VEGF) and endpoint management (EpM) grid laser versus monotherapy with anti-VEGF in the management of diabetic macular edema (DME). Methods: This was a prospective, multicenter, open-label, nonrandomized interventional study (NCT02462304). Anti-VEGF therapy consisted of one initial injection administered pro re nata in both groups. EpM laser was performed within 1 month after the first anti-VEGF injection. The main outcome evaluated was the number of anti-VEGF injections performed in 6 months. Best-corrected visual acuity (BCVA) and central foveal thickness (CFT) were also evaluated monthly. The anti-VEGF agent used in Japan and Hong Kong was ranibizumab, while bevacizumab was used in Korea. Results: This study enrolled a total of 42 subjects, with 19 (45.2%) allocated to the monotherapy arm and 23 (54.8%) allocated to the combination arm (EpM group). Overall, there was no significant difference in the number of injections between patients in the two groups (+0.12, p = 0.81). Mixed regression analysis with all the covariates plus an interaction term for the ranibizumab/bevacizumab and the monotherapy/combination arm showed that the EpM group needed 0.94 less injections (95% confidence interval [CI], -1.73 to -0.15; p = 0.02). The logarithm of the minimum angle of resolution BCVA at 24 weeks was significantly improved in the monotherapy arm (p = 0.03), but not in the EpM group (p = 0.09). CFT at 24 weeks was significantly improved in both groups (p < 0.01). Conclusions: These data suggest that combination therapy with the EpM laser may be effective for reducing the number of anti-VEGF injections required for DME treatment.

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