A clinical trial to study the effect of a drug,dapagliflozin in type 2 diabetic mellitus patient having diabetic macular edema
- Conditions
- Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients presenting to Advance Eye Centre and Endocrinology Out Patient Department with Type 2 Diabetes Mellitus > 5 years treated with insulin/ oral hypoglycemic agents except Pioglitazone
2.Patients with Diabetic Macular Edema and Non Proliferative Diabetic Retinopathy detected either with Fundus Fluorescein Angiography or Optical Coherence Tomography
3.Patients with HbA1c between 7% - 10%
4.Patients with Estimated Glomerular Filtration rate > 45 ml/min
1.Patients with Type 1 Diabetes Mellitus
2.Patients with proliferative diabetic retinopathy
3.Patients with history of treatment for Diabetic Macular Edema in the last 3 Months
4.Patients with Macular Edema due to any other cause
5.Patients with Tractional Macular Edema on OCT or those requiring surgery
6.Patients with Human Immunodeficiency Virus,Hepatitis B or C Virus, Coronary Artery Disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Assess the changes in Diabetic Macular Edema in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-transporter 2 inhibitor (Dapagliflozin)Timepoint: 3 Months
- Secondary Outcome Measures
Name Time Method To assess changes in HbA1c ,fasting and postprandial blood glucose , Serum lipid profile, Serum creatinine and Estimated Glomerular Filtration rate in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-Transporter 2 Inhibitor (Dapagliflozin)Timepoint: 3 months