A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Caliber of Choroidal New Vessel (CNV)
研究概览
简要总结
Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.
详细描述
For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
- •Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
- •Area of CNV clearly visible in ICGA is more than half of the total CNV area.
排除标准
- •CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
- •Blocked fluorescence in ICGA is more than half of the total CNV area.
- •Disciform scar
- •Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
- •Previous any treatment of photodynamic therapy or photocoagulation
- •Previous intraocular or periocular injection of steroid within 3 months
- •Previous intraocular surgery except cataract surgery
- •Vitreo-retinal interface disease on the macula
- •Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
- •Uncontrolled periocular or intraocular infection
- •History of hypersensitivity to ranibizumab treatment
- •Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
研究组 & 干预措施
ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Caliber of Choroidal New Vessel (CNV)
时间窗: 6 months
Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.
次要结局
- Visual Acuity Changes(baseline and 6 months)
- Lesion Size of CNV(6 months)
- Visual Acuity in ETDRS Letters(6 months)
研究者
Ji Eun Lee
Associate professor
Pusan National University Hospital