Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (AMD) in Vulnerable Eyes With Nonexudative AMD Trial: A Multicenter, Prospectively Randomized, Masked and Controlled, Interventional Investigator Sponsored Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Development of exudative AMD
研究概览
简要总结
This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).
详细描述
This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.
The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over 50 years old
- •Able to sign informed consent and comply with the study protocol for the duration of two years
- •Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
- •History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment
排除标准
- •Participation in another simultaneous medical investigation or clinical trial
- •Patient is pregnant, lactating, or premenopausal and not using adequate contraception
- •Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
- •Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
- •History of vitrectomy in the study eye
- •History of cataract surgery within 3 months of enrollment
- •History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
- •History of intraocular or periocular corticosteroid therapy within the past 90 days
- •History of therapeutic radiation in the region of the study eye.
- •Presence of media opacity that would preclude adequate examination and/or imaging
- •Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
- •Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
- •Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
- •Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
- •Concurrent use of systemic anti-VEGF therapy
研究组 & 干预措施
Quarterly Ranibizumab 0.5mg
Quarterly intravitreal injection of 0.5mg ranibizumab
干预措施: Ranibizumab 0.5mg (Drug)
结局指标
主要结局
Development of exudative AMD
时间窗: 2 years
Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)
次要结局
- Vision change(2 years)
- Number of injections(2 years)
- Baseline predictive factors(2 years)
- Vision loss(2 years)
- Development of geographic atrophy (GA)(2 years)
- Ocular adverse events(2 years)
- Systemic adverse events(2 years)