Sustained Disease Control in DME Patients upon Treatment Cessation with Brolucizumab.

Abstract

Background: Treatment cessation due to a dry retina has not been systematically addressed in diabetic macular edema (DME). In three out of four patients receiving 6 mg of brolucizumab in the KITE study, treatment was terminated after the study ended. Methods: The KITE study was a double-masked, multicenter, active-controlled, randomized trial (NCT03481660) in DME patients. Per protocol, patients received five loading injections of Brolucizumab at 6-week intervals, with the option to adjust to 8 weeks in case of disease activity or to extend in the second year to a maximum of 16 weeks in the absence of retinal fluid. Results: After two years, one patient required eight weekly injections, while three patients reached a maximal treatment interval of 16 weeks. The severity of diabetic retinopathy improved in all patients with no dye leakage according to fluorescein angiography (FA) and no retinal fluid according to OCT in three patients. Treatment was paused in these three patients for >36 months, while the fourth patient required continuous treatment at 5-week intervals after switching to other licensed anti-VEGF agents. Conclusions: The adoption of treatment according to individual needs, including considering treatment cessation, may contribute to improved treatment adherence in many patients and be more frequently possible than expected.