Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Mean Change in Visual Acuity Letter Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group Aflibercept
Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.
干预措施: Aflibercept (2.0 mg) (Drug)
Group Bevacizumab
Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Mean Change in Visual Acuity Letter Score
时间窗: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.
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.
次要结局
- Mean Change in Central Retinal Thickness(Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.)
研究者
Sana Javed
Principal Investigator
CMH Multan Institute of Medical Sciences
