Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aflibercept (2.0 mg), Bevacizumab.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema (DME). Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Aflibercept (2.0 mg)
Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months. - Drug Bevacizumab
Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.
Primary outcome measures
- Mean Change in Visual Acuity Letter Score [Time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.]
Secondary outcome measures (1)
- Mean Change in Central Retinal Thickness [Time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- CMH Institute of Medical Sciences — Multan
Identifiers
NCT: NCT07338097 · CIMS1