Diabetic macular edema. Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema
Conditions
Interventions
Intervention group: Intravitreal Bevacizumab and Diclofenac (IV-B/D) Vs Intravitreal Bevacizumab alone (IV-B).
Sponsors
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Eligibility
Sex/Gender
All
Age
45 Years to 78 Years
Inclusion criteria
Inclusion criteria: The ‘ETDRS’ criteria was utilized for enrollment of treatment naïve eyes of DME, defined as any hard exudates/dot blot hemorrhages, retinal thickening/edema within 500µm from the center of the fovea or involving the very center, examined clinically on fundoscopy Age range from 45 years to 78 years Type 2 DM
Exclusion criteria
Exclusion criteria: Any history of prior retinal laser therapy History of prior intravitreal injections any type Any intra-ocular procedure done within last 6 months Rubeosis irides Any glaucomatous eye damage evidence of ischemic maculopathy, defined as an enlarged foveal avascular zone (FAZ) = 1500µm; Best corrected VA of = 6/12 or = 6/120 Significant media opacity precluding fundus view Associated morbid conditions like, monocularity, pregnancy, diabetic nephropathy grade 3 and HbA1c = 10.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity improvement in Log MAR. Timepoint: Baseline, 4th, 12th and 24th week. Method of measurement: Visual acuity was measured with Snellen charts charts and than converted into Log. of minimum angle of resolution (Log MAR) units. | — |
Secondary
| Measure | Time frame |
|---|---|
| Central sub-field thickness of macula. Timepoint: Baseline, 4th, 12th and 24th week. Method of measurement: Macular thickness was measured in microns. | — |
Countries
Pakistan
Contacts
Public ContactNizam Darwesh
Nowshera Medical College
Outcome results
None listed