The potential effect of Dapagliflozin on diabetic macular edema

Not Applicable

• Conditions: diabetic macular edema, diabetes

• Registration Number: JPRN-UMIN000020331
• Lead Sponsor: Kyoto Prefectural University of Medicine Department of Endocrinology and Metabolism

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-24
• Study Completion: 2016-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Refusal or lack of capacity to give informed consent The contraindications use of Dapagliflozin History of SGLT2i eGFR <45mL/min/1.73m2 Anti GAD antibody positive Pregnant or current Brest feeding Recent history of cardiovascular events AST and/or ALT > 3x upper limit of normal Total bilirubin > 3.0 mg/d

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of macular edema (the thickness and the area) at 12th week from baseline.

Secondary Outcome Measures

Name	Time	Method
Glycemic control; e.g. blood glucose, HbA1c osmotic pressure serum creatinine, eGFR, urinary albmin creatinine ratio, the frequency of ophtharmological treatment The severity and causal relationship with the investigational drug will be tabulated and evaluated for adverse events occurring during the study period.