The potential effect of Dapagliflozin on diabetic macular edema

The potential effect of Dapagliflozin on diabetic macular edema - The potential effect of Dapagliflozin on diabetic macular edema

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020331

Enrollment

Registered

2015-12-24

Start date

2016-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular edema, diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: subjects giving informed consent to participate in the trial HbA1c: 6.5-9.5 (NGSP) age: 20-75 BMI: 22-45

Exclusion criteria

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/dL

Design outcomes

Primary

Measure	Time frame
The change of macular edema (the thickness and the area) at 12th week from baseline.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactMasahiro Yamazaki

Kyoto Prefectural University of Medicine Department of Endocrinology and Metabolism

masahiro@koto.kpu-m.ac.jp075-251-5505

Outcome results