Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

CMH Multan Institute of Medical Sciences

Status: Invitation-only

Conditions: Diabetic Macular Edema (DME)

Treatments: Drug: Bevacizumab; Drug: Aflibercept (2.0 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07338097

CIMS1

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Group Aflibercept

Experimental group

Description:

Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.

Treatment:

Drug: Aflibercept (2.0 mg)

Group Bevacizumab

Active Comparator group

Description:

Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months

Treatment:

Drug: Bevacizumab