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.

Keywords: KITE&KESTREL studies; anti-VEGF agents; brolucizumab; case series; diabetic macular edema; intravitreal therapy; treatment cessation.

Figure 1

Patient 1, m, at diagnosis of diabetic macular edema 74 years old, with oral well-controlled diabetes mellitus type 2 for more than 20 years. (A) Redfree and late fluorescein angiographic images at treatment initiation. (B) Late fluorescein angiographic and OCT images after 2 years (left) and OCT at brolucizumab treatment initiation (baseline) and after 2 and 5 years (right).

Figure 1

Patient 1, m, at diagnosis of diabetic macular edema 74 years old, with oral well-controlled diabetes mellitus type 2 for more than 20 years. (A) Redfree and late fluorescein angiographic images at treatment initiation. (B) Late fluorescein angiographic and OCT images after 2 years (left) and OCT at brolucizumab treatment initiation (baseline) and after 2 and 5 years (right).

Figure 2

Patient 2, m, upon diagnosis of diabetic macular edema 78 years old, moderately controlled diabetes mellitus type 2 since 20 years, insulin dependent. (A) Redfree and late fluorescein angiographic images upon treatment initiation. (B) Redfree and late fluorescein angiographic images after 2 years. (C) OCT images at initiation of brolucizumab treatment (baseline) and after 2 and 5 years.

Figure 2

Patient 2, m, upon diagnosis of diabetic macular edema 78 years old, moderately controlled diabetes mellitus type 2 since 20 years, insulin dependent. (A) Redfree and late fluorescein angiographic images upon treatment initiation. (B) Redfree and late fluorescein angiographic images after 2 years. (C) OCT images at initiation of brolucizumab treatment (baseline) and after 2 and 5 years.

Figure 3

Patient 3, f, upon diagnosis of diabetic macular edema 73 years old, moderately controlled diabetes mellitus type 2 since 34 years, insulin dependent. (A) Redfree and late fluorescein angiographic images at treatment initiation. (B) late fluorescein angiographic images (left) and OCT images upon initiation of brolucizumab treatment (baseline) and after 2 and 5 years (right).

Figure 4

Patient 4, m, upon diagnosis of diabetic macular edema 66 years old, diabetes mellitus type 2 for 20 years, insulin dependent, except for controlled arterial hypertension, no comorbidity. (A) Redfree and late fluorescein angiographic images at treatment initiation. (B) OCT images upon initiation of brolucizumab treatment and after 2 and 5 years (4 weeks after the last intravitreal aflibercept injection).