Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Intensive Statin Therapy: Participants will be prescribed high-dose statins, primarily Atorvastatin 40 80 mg/day or an equivalent statin, with the aim to achieve and maintain LDL-C 70 m
Sponsors
Self funded
Eligibility
Inclusion criteria
Inclusion criteria: 1)Adults aged 30 to 75 years. 2)Diagnosed with type 2 diabetes mellitus. 3)Presence of diabetic retinopathy confirmed through seven-field ETDRS-standard fundus photography. 4)Elevated LDL-C levels (greater than or equal to 100 mg/dL). 5)No prior history of coronary artery disease. 6)Ability and willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Advanced renal failure (eGFR less than 30 mL/min/1.73 m ). 2). Pregnancy or intention to become pregnant during the study period. 3). Presence of other retinal diseases (e.g., retinal vein occlusion, age-related macular degeneration) unrelated to diabetic retinopathy. 4). Known hypersensitivity or contraindications to statins. 5). Inability to adhere to study protocol or scheduled follow-ups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: oChange of two or more steps on the DR severity scale at 48 months, assessed using seven-field fundus photography. Photographs will be graded by two masked retinal specialists. Secondary Endpoints: oChanges in the ETDRS hard exudate severity scale. oChanges in best-corrected visual acuity (BCVA), measured as logMAR. oNeed for additional ocular treatments (example panretinal photocoagulation, focal/grid macular photocoagulation, vitrectomy, or ocular medical therapies such as steroids or anti-VEGF agents). Timepoint: The study will follow patients for a duration of 4 years with assessments at baseline, 24 months, and 48 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| o Changes in the ETDRS hard exudate severity scale and changes in best-corrected visual acuity (BCVA), measured as logMAR. Timepoint: Both groups will have quarterly lipid profile monitoring during the first year, followed by biannual checks. Fundus photographs will be taken at baseline, 24 months, and 48 months to assess DR progression.;o Need for additional ocular treatments (e.g., panretinal photocoagulation, focal/grid macular photocoagulation, vitrectomy, or ocular medical therapies such as steroids or anti-VEGF agents).Timepoint: Both groups will have quarterly lipid profile monitoring during the first year, followed by biannual checks. Fundus photographs will be taken at baseline, 24 months, and 48 months to assess DR progression. | — |
Countries
India
Contacts
Public ContactDr Phulen Sarma
AIIMS Guwahati
Outcome results
None listed