INTRAVITREAL DICLOFENAC PLUS BEVACIZUMAB VERSUS BEVACIZUMAB ALONE IN THE TREATMENT OF DIABETIC MACULAR EDEMA

Not Applicable

Conditions: Diabetic macular edema.
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema
E08.341

Registration Number: IRCT20220607055097N1

Lead Sponsor: owshera Medical College/ Qazi Hussain Ahmad Medical Complex

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Central sub-field thickness of macula. Timepoint: Baseline, 4th, 12th and 24th week. Method of measurement: Macular thickness was measured in microns.