An Open-Label, Single-Site, Comparative, Pilot Study of the Treatment Effects of Combination Therapy of Lucentis (Ranibizumab) Plus Reduced Fluence Photodynamic Therapy With Visudyne in Patients With Exudative Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the safety of the combination therapy
研究概览
简要总结
The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.
详细描述
The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.
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
- •Ability to give informed consent
- •Treatment- naïve patients with active, subfoveal, exudative AMD
- •Patients with visual acuity of 20/40-20/320 in the study eye
- •Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
- •The lesion must be < 5400microns in greatest linear dimension (GLD)
- •Lesion size < 10 DA
- •Occult with no classic CNV lesions must have presumed recent disease progression:
- •Blood associated with the lesion at baseline
- •Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
- •> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
- •Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
- •Geographic atrophy or fibrosis in the study eye
- •Intraocular surgery within 6 weeks of enrollment
- •Subretinal hemorrhage > 50% of the total lesion
- •Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
- •Patients with severe disciform scarring.
- •Inability to make study visits
- •Advanced glaucoma
- •Allergies to porfins or a known hypersensitivity to any component of Visudyne®
- •Patients with porphyria
- •Pregnancy or lactation
排除标准
- 未提供
研究组 & 干预措施
Lucentis plus Reduced Fluence PDT same day
干预措施: reduced fluence photodynamic therapy with Visudyne (Drug)
Lucentis plus Reduced Fluence PDT same day
干预措施: Lucentis (Drug)
Lucentis plus reduced fluence PDT 1-2 weeks later
干预措施: reduced fluence photodynamic therapy with Visudyne (Drug)
Lucentis plus reduced fluence PDT 1-2 weeks later
干预措施: Lucentis (Drug)
结局指标
主要结局
To assess the safety of the combination therapy
时间窗: 12 months and 24 months
To assess efficacy of the two timing regimens
时间窗: 12 months and 24 months
次要结局
- To evaluate the number of Lucentis injections and the number of PDT treatments required during the study(12 months and 24 months)