macular edema in type 2 diabetic patients. Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: empagliflozin, 10 mg, once daily, three months, oral, Abidi pharmacy. Intervention 2: Control group: placebo, like empagliflozin but has starch as an ingredient, on
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: patients with type 2 diabetes BMI:20-40 HbA1C less than 9% blood pressure less than 140/90 mmHg No change in treatment of diabetes in the past 3 months central subfield thickness (CST) more than 320 microns with or without cystic changes Snellen visual acuity less than 20/30 and better than 20/400
Exclusion criteria
Exclusion criteria: history of diabetic ketoacidosis (DKA) in the past 3 months, , history of more than one urogenital infection in a year history of chronic or recurrent urinary tract infection(UTI) estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 chronic diarrhea History of SGLT2 inhibitors usage in the previous 3 months chronic liver disease diuretic use alcohol or drug abuse pregnant women or those who have a plan for pregnancy, breastfeeding women concomitant proliferative diabetic retinopathy (PDR) history of laser therapy to macula history of PRP laser in the last 6 months presence of a membrane on the retina which has caused a significant traction any ocular surgery except cataract surgery in the previous six months any ocular pathology with effect on retinal thickness or visual acuity uncontrolled glaucoma history of treatment with systemic or ocular steroid. history of intravitreal injection in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central subfield thickness. Timepoint: at baseline and then monthly until 3months. Method of measurement: and optical coherence tomography (OCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity. Timepoint: at baseline and then monthly until 3months. Method of measurement: Snellen chart. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Ebrahim Khamseh
Iran University of Medical Sciences
Outcome results
None listed