Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
研究概览
简要总结
The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
详细描述
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 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.
- •Age > 50 years
- •Definite characteristic signs of age related macular degeneration including drusen
- •Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)
排除标准
- •Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
- •Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
- •Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- •Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
- •History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
研究组 & 干预措施
1
Lucentis 0.3mg/0.05 ml
干预措施: Lucentis (Drug)
1
Lucentis 0.3mg/0.05 ml
干预措施: Ranibizumab (Drug)
1
Lucentis 0.3mg/0.05 ml
干预措施: Ranibizumab (Lucentis) (Drug)
2
Lucentis 0.5mg/0.05 ml
干预措施: Lucentis (Drug)
2
Lucentis 0.5mg/0.05 ml
干预措施: Ranibizumab (Drug)
2
Lucentis 0.5mg/0.05 ml
干预措施: Ranibizumab (Lucentis) (Drug)
结局指标
主要结局
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
时间窗: 2 years
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
时间窗: 12 months
Incidence and severity of ocular adverse events
时间窗: 12 months
Incidence and severity of non-ocular adverse events
时间窗: 12 months
Changes in vital signs
时间窗: 12 months
次要结局
- Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions(12 months)
- Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT(2 years)
- Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG(2 years)
- Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography(2 years)
- Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses(2 years)
- Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination(2 years)