Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia: 48 Weeks Study Results
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Mean change in best-corrected visual acuity (BCVA) from baseline
研究概览
简要总结
To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization secondary to pathologic myopia (PM).
详细描述
Sixty patients received ranibizumab 0.5 mg combined with reduced fluence (RF) verteporfin PDT. Ranibizumab was first administered to patients followed after seven days by RF-PDT. Subsequently intravitreal ranibizumab (IVR) was injected as needed (pro re nata). All patients were evaluated every 4 weeks for 48 weeks.
Main Outcome Measures: Mean change in best-corrected visual acuity (BCVA) from baseline at 48 weeks, reduced mean central foveal thickness (CFT) analyzed by optical coherence tomography (OCT) and improved macular sensitivity registered at microperimetry (MP) evaluation.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologic myopia, defined as spherical equivalent greater than 6 D and axial length more than 26 mm (Carl Zeiss IOLMaster V 4.07; Carl Zeiss Meditec, Dublin, California, USA);
- •posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
- •fluorescein angiography (FA) detection of the subfoveal or juxtafoveal CNV (CNV was classified as juxta-foveal if the lesion was closer than 200 mm but not under the geometric center of the foveal avascular zone);
- •clear ocular media;
- •duration of symptoms no longer than 4 weeks before enrollment.
排除标准
- •prior treatment for CNV including previous intravitreal drugs injection or PDT-V;
- •presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion;
- •history of recent myocardial infarction or other thromboembolic events;
- •ongoing uncontrolled hypertension or glaucoma;
- •refractive media opacities;
- •eye surgery.
研究组 & 干预措施
PDT Standard Fluence, ranibizumab
verteporfin (6 mg/m2) SF (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 milliwatt(mW)/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab
干预措施: PDT standard fluence, ranibizumab (Drug)
PDT Reduced Fluence, ranibizumab
verteporfin (6 mg/m2) RF ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab
干预措施: PDT reduced fluence, ranibizumab (Drug)
ranibizumab
0.5 mg (10 mg/ml) intravitreal ranibizumab.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Mean change in best-corrected visual acuity (BCVA) from baseline
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Chiosi Flavia
MD
University of Campania "Luigi Vanvitelli"