Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: ATORVASTATIN: LOW DOSE (10-20 mg ) oral everyday for entire period of study
Control Intervention1: ATORVASTATIN: HIGH DOSE (40-80 mg) oral everyday for entire duration of study
Sponsors
ADVANCED EYE CENTER
Eligibility
Inclusion criteria
Inclusion criteria: Following will be the inclusion criteria: Patients with Non proliferative diabetic retinopathy(NPDR) and clinically significant macular edema(CSME), who are treatment naïve (not having received any form of treatment for CSME in the form of anti-VEGF, intravitreal steroids or laser therapy). Patients who are not treatment naive, but have received any form of above mentioned therapy for CSME atleast three months prior to enrolment. Patients who have not received any previous statin therapy (or are off statin therapy for at least six months). 4. Patients willing to give consent and come for regular follow ups.
Exclusion criteria
Exclusion criteria: Patients with proliferative diabetic retinopathy, pregnant or lactating women, patients with hepatic or renal insufficiency, any evidence of systemic inflammation or malignancy, patients with increased creatine phosphokinase or deranged liver function tests (LFTs0 or kidney function tests (KFTs) will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NUMBER OF ANTI VASCULAR ENDOTHELIAL GROWTH FACTOR INJECTION REQUIREDTimepoint: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| BEST CORRECTED VISUAL ACUITYTimepoint: 9 MONTHS;CENTRAL MACULAR THICKNESSTimepoint: 9 MONTHS;SERUM VEGF LEVELSTimepoint: BASELINE, 3 MONTHS AND 9 MONTHS | — |
Countries
India
Contacts
Public ContactASHISH MARKAN
ADVANCED EYE CENTRE, PGIMER, CHANDIGARH
Outcome results
None listed