Comparison of Early Intervention of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV Patients With Initial Loading Dose
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Change in central retinal thickness
研究概览
简要总结
The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
详细描述
PCV is generally recognized as a subtype of wet AMD characterized by the presence of aneurysmal orange-red polypoidal lesions with or without branching vascular network (BVN) in the choroidal vasculature as observed on indocyanine angiography (ICGA), representing 13% to 54.7% of newly diagnosed patients with neovascular AMD. Fifty percent of PCV had persistent leakage or recurrent bleeding with poor visual outcome, if left untreated.
And in the EVEREST study has shown that synergistic effects of anti-VEGF and vPDT combination: vPDT strongly regress polyp and anti-VEGF control to up-regulation of VEGF induced by vPDT compared to ranibizumab monotherapy in newly diagnosed PCV patients. Additionally, combination offers an opportunity for individualized treatment with potentially fewer treatments and less costs.
Therefore, the aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or older than 50 years
- •Insufficient responder to ranibizumab Tx
- •ICGA-confirmed PCV
- •BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
排除标准
- •Prior treatment with other anti-VEGF treatments in the study eye.
- •Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
- •Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
- •Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
- •Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- •Previous submacular surgery in the study eye
- •A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia
- •Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma
- •Previous participation in a clinical trial involving anti-angiogenic drugs
- •Intraocular surgery: 2 months before Visit 1 in the study eye.
- •Previous participation in any studies of investigational drugs
- •Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.
研究组 & 干预措施
combination Tx
combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)
干预措施: PDT (Procedure)
combination Tx
combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)
干预措施: ranibizumab PRN (Drug)
mono Tx
Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6)
干预措施: Ranibizumab (Drug)
mono Tx
Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6)
干预措施: ranibizumab PRN (Drug)
结局指标
主要结局
Change in central retinal thickness
时间窗: after 6month
Change in central retinal thickness measured by OCT
次要结局
- Change of ETDRS BCVA(after 6month)