NCT01011374Unknown1 期
Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion
Retina Associates of Cleveland, Inc1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
研究概览
简要总结
This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.
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
- 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
- 是
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam
- •Age 18 years or over
- •Central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns
- •Visual acuity ranging from 20/8000 to 20/40
- •Media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA
- •No previous treatment that might compromise or confound assessment of the study outcomes
- •Ability to speak and read English
排除标准
- •Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements
- •Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise
- •History of grid/focal laser in the study eye
- •History of vitreal surgery
- •Previous treatment with triamcinolone acetonide in either eye
- •Previous use of bevacizumab, pegaptanib, or ranibizumab in either eye
- •Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- •History of cerebrovascular accident within 1 year prior to Day 0
- •Inability to comply with study or follow-up procedures
- •Any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results
- •Visual acuity better than 20/40
- •Pregnancy (positive pregnancy test) or lactation
- •Inadequate contraception in premenopausal women
结局指标
主要结局
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
时间窗: 24 weeks
次要结局
- Secondary outcome measures are change in macular edema measured by OCT and estimated by central retinal thickening and correlations between change in visual acuity, depression, and retinal findings such as neovascularization, rubeosis, and perfusion.(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
A study to evaluate the effect of Lucentis® (Ranibizumab) on Vision Related Function using the VFQ-25 questionnaire in patients with wet age-related macular degeneration (AMD)CTRI/2010/091/000379ovartis health care private limited500
已完成
3 期
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)Macular EdemaRetinal Vein OcclusionNCT00942864Novartis Korea Ltd.40
Unknown
2 期
Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein OcclusionRetinal Vein OcclusionMacular EdemaNCT01123564University of Pecs40
已完成
不适用
Efficacy of repeated intravitreal Lucentis (Ranibizumab) injection according to the genotypic characteristics of exudative age-related macular degeneration in KoreansDiseases of the eye and adnexaKCT0002531Seoul National University Hospital300
Unknown
4 期
Use of Intravitreal Ranibizumab in the Treatment of Vitreous HemorrhageVitreous HemorrhageDiabetic RetinopathyNCT01824043Hospital Regional de São José - Dr. Homero de Miranda Gomes20