NCT05112861进行中（未招募）3 期
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS
研究概览
简要总结
The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy
排除标准
- •Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
- •Previous use of Beovu®
- •Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
- •History of inadequate response to previous intravitreal anti-VEGF therapy
- •History of any intraocular or periocular corticosteroid injection or implant, in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
- •Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
- •Active intraocular inflammation in the study eye
- •Current vitreous hemorrhage in the study eye
- •Polypoidal choroidal vasculopathy (PCV) in the study eye
- •History of idiopathic, infectious or autoimmune-associated uveitis in either eye
- •Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
- •Premenopausal women not using adequate contraception
- •Current treatment for active systemic infection
- •Known allergy to any component of the study drug , not amenable to treatment
研究组 & 干预措施
Biological: bevacizumab
Experimental
干预措施: bevacizumab (Biological)
结局指标
主要结局
Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (4)
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