Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Intravitreal injection of anti-VEGF, Bevacizumab 1.25 mg/0.05 mL (Avastin): Bevacizumab (Avastin®
Genentech, Inc., South San Francisco, CA) is a humanized anti-VEGF monoclonal IgG1 antibody (molecular weight, 149 kDa).
Control Intervention1: Atorvastatin 20 mg/day for 6 months: Atorvastatin is a l
Sponsors
Manisha Agarwal
Pramod Upadhyay
Eligibility
Inclusion criteria
Inclusion criteria: Treatment naïve patients or previously treated patients (beyond 3 months of enrolment) with non-proliferative or proliferative diabetic retinopathy with centre involving DME; Central macular thickness (CMT) measured on optical coherence tomography angiography (OCTA) of �250 microns; Serum glycated hemoglobin level
Exclusion criteria
Exclusion criteria: Vitrectomised eyes or any other intraocular surgery, injection or laser within last 3 months; Other macular pathologies like ARMD, etc.; Significant media haze ; Abnormal renal or liver parameters; Allergy to atprvastatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in aqueous and plasma VEGF levelsTimepoint: AT 0,2,4,6 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Central macular thickness and visual acuityTimepoint: AT 0,1,2,3,4,5,6 months | — |
Countries
India
Contacts
Public ContactChanda Gupta
Dr. Shroffâ??s Charity Eye Hospital
Outcome results
None listed