Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
研究概览
简要总结
To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients are men or women of age 50 or older.
- •Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
- •Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
- •The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
- •Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.
- •The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion.
- •The CNV is associated with only macular degeneration.
- •Patient defers other approved treatments of subfoveal CNV associated with AMD.
排除标准
- •Prior treatment for subfoveal choroidal neovascularization (CNV).
- •Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
- •History of vitrectomy or submacular surgery in the study eye.
- •Subretinal fibrosis accounting for more than 50% of the lesion.
- •Non-CNV lesion components account for more than 50% of the total lesion components.
- •CNV due to causes other than AMD.
- •Retinal pigmented epithelial tear involving the center of the macula.
- •Geographic atrophy involving the central macula.
- •Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract).
- •Active intraocular inflammation.
- •Vitreous hemorrhage in the eye.
- •History of spherical equivalent in the study eye greater than negative 8 diopters.
- •Intraocular surgery within 2 months of study enrollment.
- •Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication.
- •History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication.
- •Inability to comply with study or follow-up procedures.
研究组 & 干预措施
A
Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
干预措施: Bevacizumab (Drug)
A
Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
干预措施: verteporfin photodynamic therapy reduced fluence (Device)
B
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
干预措施: Bevacizumab (Drug)
B
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
干预措施: verteporfin photodynamic therapy standardfluence (Device)
结局指标
主要结局
Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
时间窗: 1 Year
次要结局
未报告次要终点
研究者
Dante Pieramici
Director of Research
California Retina Consultants