NCT01255774Unknown3 期
Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO) And The Foresee Preferential Hyperacuity Perimeter
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Central retinal thickness
研究概览
简要总结
The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.
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
- 51 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Subjects of either gender, Age > 50 years
- •Best corrected visual acuity in the study eye between 20/40 and 20/
- •Subfoveal choroidal neovascularization, secondary to age related macular degeneration.
- •Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
- •Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography
- •Men must use barrier contraception or abstinence throughout the study.
- •Ability to return for all study visits
排除标准
- •Had ocular surgery within the past 60 days in the study eye.
- •Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye.
- •Has intraocular pressure ≥ 25 mmHg in the study eye.
- •Has posterior uveitis in the study eye.
- •Has ongoing infection in the study eye.
- •Has retinal or optic nerve disease that could independently affect visual acuity including high axial myopia (>-8.00 D) and diabetic retinopathy in the study eye.
- •Has anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs and fluorescein angiography in the study eye.
- •Has received investigational therapy within 60 days prior to study entry.
- •Has been previously enrolled in or previous treatment with MSI-1256F for injection.
- •Has received prior approved treatment for subfoveal CNV within 60 days to study entry.
- •Has clinically uncontrolled diabetes mellitus.
- •Has other condition the investigator considers to be sound reasons for exclusion (e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up).
- •Has an allergy to sodium fluorescein dye.
- •Currently uses systemic or topical medications known to be toxic to the retina, lens, or optic nerve, such as deferoxamine, chloroquine/hydrochloroquine, tamoxifen, chlorpromazine, phenothiazines, steroids and ethambutol.
- •Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
研究组 & 干预措施
Ranibizumab
Experimental
Open Label use of Ranibizumab for wet age related macular degeneration
干预措施: ranibizumab (Drug)
结局指标
主要结局
Central retinal thickness
时间窗: 12 months
To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.
次要结局
- change in central scotoma lesion size, density and distortion due to neovascularization(12 months)
研究者
研究点 (1)
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