Efficacy of Fixed Monthly Dosing of Lucentis® (Ranibizumab) on Subretinal Fluid (SRF) Associated With Persistent Pigment Epithelial Detachment (PED) in Neovascular Age-related Macular Degeneration (AMD): A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of subretinal fluid (SRF)
研究概览
简要总结
The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.
详细描述
PEDs occur in up to 62% of eyes with advanced AMD. Numerous treatment options have been employed for PEDs in AMD, including laser therapies and intravitreal injections of anti-VEGF antibodies. However, eyes with PEDs were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular AMD; therefore, the efficacy of such options is still unclear for eyes with PEDs in neovascular AMD. Additionally, PED lesions have been reported to show less morphological and functional response to anti-VEGF monotherapy than eyes with other CNV lesions subtypes.
Based on the generally poor prognosis of PEDs and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of Lucentis® (Ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of Ranibizumab for the treatment of SRF associated with PED in neovascular AMD which is persistent to previous anti-VEGF monotherapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lucentis
Lucentis fixed treatment
干预措施: Lucentis (Drug)
结局指标
主要结局
Changes of subretinal fluid (SRF)
时间窗: Baseline and 6 months
Maximum diameter
Changes of a pigment epithelial detachment (PED)
时间窗: Baseline and 6 months
Maximum diameter
次要结局
- The incidence of ocular adverse events(Through study completion, an average of 1 year)
- The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline(Baseline and 6 months)
- Change in best corrected visual acuity from baseline(Baseline and 6 months)
- Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline(Baseline and 6 months)
- The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED)(Baseline and 6 months)
- The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED)(Baseline and 6 months)
- The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)(Baseline and 6 months)
- The proportion of cases experiencing leakage from neovascular AMD lesions(Baseline and 6 months)
- The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)(Baseline and 6 months)