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- Title
Safety and Efficacy of Ranibizumab and Luseogliflozin Combination Therapy in Patients with Diabetic Macular Edema: Protocol for a Multicenter, Open-Label Randomized Controlled Trial.
- Authors
Ishibashi, Ryoichi; Takatsuna, Yoko; Koshizaka, Masaya; Tatsumi, Tomoaki; Takahashi, Sho; Nagashima, Kengo; Asaumi, Noriko; Arai, Miyuki; Shimada, Fumio; Tachibana, Kaori; Watanabe, Yoshihiro; Ishikawa, Ko; Hoshino, Akiko; Yamamoto, Kyohei; Kubota-Taniai, Mariko; Mayama, Takafumi; Yamamoto, Shuichi; Yokote, Koutaro
- Abstract
Introduction: Diabetic macular edema (DME) threatens daily life activities such as reading and driving and reduces the patients' quality-of-life. Recently, anti-vascular endothelial growth factor (VEGF) agents have become a first-line therapy in DME. However, therapy with anti-VEGF agents has several problems: repeated invasive injections are required; medical costs are high; and a certain proportion of patients with DME are resistant to treatment with anti-VEGF agents. While sodium-glucose co-transporter 2 (SGLT2) inhibitors have been widely used for the treatment of type 2 diabetes mellitus (T2DM), the effects of a combination therapy with anti-VEGF agent and SGLT2 inhibitor on DME are not yet known. Methods: This study enrolls subjects with T2DM and DME, randomizes them into either a study agent treatment group (treated with ranibizumab as anti-VEGF agent and luseogliflozin as SGLT2 inhibitor) or a control group (treated with ranibizumab and glimepiride), and observes the subjects for 52 weeks after initiation of treatment. Planned outcomes: The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48. Secondary and exploratory endpoints include safety and ophthalmologic and internal medical clinical parameters. Registration: This study is registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN000033961) and Japan Registry of Clinical Trials (jRCTs031180210).
- Subjects
UNIVERSITY of Colorado Hospital; LASER photocoagulation; PEOPLE with diabetes; VASCULAR endothelial growth factor antagonists; ENDOTHELIAL growth factors; CLINICAL trial registries; RANIBIZUMAB
- Publication
Diabetes Therapy, 2020, Vol 11, Issue 8, p1891
- ISSN
1869-6953
- Publication type
Article
- DOI
10.1007/s13300-020-00854-6