Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in monocular BCVA in the treatment eye
研究概览
简要总结
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.
详细描述
The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any study assessment is performed
- •Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- •BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
- •Central foveal thickness (CFT) ≥ 300 µm
排除标准
- •Pregnant or nursing (lactating) women
- •Stroke or myocardial infarction less than 3 months before Screening
- •Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- •Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- •Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- •Neovascularization of the iris or neovascular glaucoma in the study eye
- •Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- •Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye
- •Focal or grid laser photocoagulation in the study eye
- •Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
- •Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
研究组 & 干预措施
BRVO: Bevacizumab and intravitreal Dexamethasone
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
干预措施: Bevacizumab Ophthalmic and Intravitreal Dexamethasone (Drug)
BRVO: Bevacizumab
Participants with BRVO will receive Bevacizumab only.
干预措施: Bevacizumab Ophthalmic (Drug)
结局指标
主要结局
Mean change in monocular BCVA in the treatment eye
时间窗: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Mean change in binocular BCVA
时间窗: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
次要结局
- Mean change in central subfield retinal thickness(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Change in Humphrey 10-2 visual field in the treatment eye(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Side effects(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Number of Bevacizumab. Treatments(Day 1 through Month 6)
- Mean change in NEI VFQ25(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in EQ-5D 5L(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in VisQoL scores(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in wavefront aberrations(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in ocular surface and tear-film(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in vessel density(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)
- People meeting driving standards(Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.)