Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

N/AEnrolling By InvitationNCT07338097

CMH Multan Institute of Medical Sciences116 enrolled

Overview

Diabetic macular edema is a frequent complication of long-standing diabetes mellitus in which fluid leaks into the central part of the retina (macula), leading to reduced vision. This randomized controlled trial will be conducted at Combined Military Hospital, Multan, to compare two commonly used intravitreal anti vascular endothelial growth factor medicines, aflibercept and bevacizumab, in adults aged 30 to 60 years with type 1 or type 2 diabetes mellitus for at least 5 years, central macular thickness of at least 300 micrometers on optical coherence tomography, and reduced baseline visual acuity (20/50 or worse). Eligible participants will be allocated in a 1:1 ratio to receive either intravitreal aflibercept 2.0 mg or intravitreal bevacizumab 1.25 mg, administered monthly for two months, with follow-up assessments at 1 and 2 months. The primary hypothesis is that aflibercept produces a greater average improvement in visual acuity than bevacizumab in this patient group. The primary outcome is the mean change in visual acuity measured as Early Treatment Diabetic Retinopathy Study letter score from baseline to 2 months. The secondary outcome is the mean change in central retinal thickness on optical coherence tomography.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

116

Conditions

Diabetic Macular Edema (DME)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with type 1 or type 2 diabetes mellitus for ≥5 years * Baseline visual acuity of 20/50 or worse * Central macular thickness of ≥300 µm on OCT * Age 30 to 60 years * Either gender * Provided voluntary consent for participation Exclusion Criteria: * History of prior treatment for DME: anti-VEGF, steroids, or laser. * Active ocular infection or inflammation * History of cardiac disease or stroke * Women who are pregnant or breastfeeding * Known allergy to Aflibercept or Bevacizumab * Patient refusals to participate in the study

Outcomes

Primary Outcomes

Mean Change in Visual Acuity Letter Score

The primary outcome is the average change in visual acuity expressed as Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, calculated by converting Snellen visual acuity measurements. The change is determined by subtracting baseline letter score from the letter score measured at follow up. This metric reflects functional improvement in vision.

Time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.

Secondary Outcomes

Mean Change in Central Retinal Thickness

The secondary outcome is the average change in central retinal thickness measured in micrometers using optical coherence tomography. The change is calculated by comparing baseline thickness with the value measured at follow up. This outcome reflects anatomical response of the macula to treatment.