Health Condition 1: E083- Diabetes mellitus due to underlying condition with ophthalmic complications
Conditions
Interventions
Intervention1: Fenofibrate: Participants in the intervention arm will receive fenofibrate 135 mg, taken once daily for 3 months
Control Intervention1: Placebo: Participants in the comparator arm will
Sponsors
Nehru Hospital PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals aged 18 years and above, of either sex, diagnosed with diabetic retinopathy. 2. Duration of diabetes mellitus for more than one year. 3. Ocular treatment na ve patients with mild diabetic retinopathy to severe non-proliferative diabetic retinopathy, with no diabetic macular edema (DME) or non-centre-involving DME (nci-DME). 4. Patients with untreated or treated resting mean sitting systolic blood pressure
Exclusion criteria
Exclusion criteria: 1.Known allergy to fenofibrate. 2.Chronic kidney disease or estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m². 3.Serum ALT greater than 3 times the ULN. 4.History of photosensitivity or myopathy/rhabdomyolysis. 5.History of pancreatitis, deep vein thrombosis, gall bladder disease, or untreated hypothyroidism. 6.Record of the occurrence or current existence of proliferative retinopathy. 7.History or presence of center-involving diabetic macular edema (ci-DME). 8.Coexisting macular diseases other than DME. 9.Historical records or documented instances of photocoagulation of the retina or intravitreal injections. 10.Patients on coumarin anticoagulant therapy. 11.Pregnant and lactating women. 12.Degree of cataract or media opacity that hinders the ability to acquire gradable retinal photographs. 13.Angle-closure glaucoma which prevents pharmacological dilation of the pupil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be advancing two or more steps for participants who had any DR at baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale, based on evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period, or both (ETDRS 1991)Timepoint: At baseline and at 3 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients converting from NPDR lower grade to NPDR higher grade Number of patients converting from NPDR to PDR Number of patients converting from no DME to DME Number of patients converting from non centre involving DME to centre involving DME Mean change in visual acuity Mean change in central 1 mm OCT thickness Mean change in vision related quality of life Discontinuation of treatment Adverse effects including serious adverse eventsTimepoint: Baseline, At the end of 3 months of followup | — |
Countries
India
Contacts
Public ContactDr Ashish Kakkar
Postgraduate Institute of Medical Education and Research
Outcome results
None listed