Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity BCVA
研究概览
简要总结
this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old
详细描述
This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.
Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will receive intravitreal injection of 2.0 mg\0.1 ml Aflibercept. All patients will be followed up for 12 months.
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
- — 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients younger than 50 years with macular edema due to non-ischemic CRVO
排除标准
- •Other conditions that might affect the macula as
- •diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
- •patients with ischemic type CRVO and patients who had recent intraocular surgery.
- •patients who had previous intravitreal injections, ophthalmic laser surgeries.
- •patients with dense cataracts whom fundus was difficult to scan.
- •Patients who were lost to follow up visits were also excluded
研究组 & 干预措施
Aflibercept group
Aflibercept injection monthly for 3 successive months
干预措施: Aflibercept (Drug)
Ranibizumab group
Ranibizumab injection monthly for 3 successive months
干预措施: intravitreal injection of Ranibizumab (Procedure)
Ranibizumab group
Ranibizumab injection monthly for 3 successive months
干预措施: Ranibizumab (Drug)
Aflibercept group
Aflibercept injection monthly for 3 successive months
干预措施: intravitreal injection of Aflipercept (Procedure)
结局指标
主要结局
Best corrected visual acuity BCVA
时间窗: at 12 months post-injection
change BCVA after injection
次要结局
- reduction of macular edema(at 12 months post-injection)
研究者
Ahmed Ali Ahmed Amer
Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt
South Valley University