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临床试验/NCT07338097
NCT07338097Enrolling By Invitation不适用

Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

CMH Multan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年9月7日最近更新:
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
CMH Multan Institute of Medical Sciences
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sana Javed

Principal Investigator

CMH Multan Institute of Medical Sciences

研究点 (1)

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