Study on Central 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 purpose of this study is to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone.
详细描述
Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO.
Bevacizumab, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Bevacizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.
Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.
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 CRVO
- •BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
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 antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- •Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
- •Focal or grid laser photocoagulation within 4 months before Baseline 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
CRVO: Bevacizumab and intravitreal Dexamethasone.
Participants with CRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
干预措施: Bevacizumab Ophthalmic and Intravitreal Dexamethasone. (Drug)
CRVO: Bevacizumab
Participants with CRVO will receive a combination of 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.
Mean change in binocular BCVA
时间窗: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters.
次要结局
- Side effects(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Use of additional treatments (including laser)(Day 1 through Month 6)
- People meeting driving standards(Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in central subfield retinal thickness(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Change in Humphrey 10-2 visual field in the treatment eye(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Number of Ranibizumab Treatments(Day 1 through Month 6)
- Mean change in NEI VFQ25 Questionnaire Score(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in VisQoL scores(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in wavefront aberrations(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in ocular surface and tear-film(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in vessel density(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)