Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Injection Number
研究概览
简要总结
The purpose of this study is to compare the efficacy (times of injection, change of visual acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological myopia choroidal neovascularization (PM-CNV).
详细描述
PM is a common disease in east asia, while PM-CNV affect 5%-10% PM patients.PM-CNV has specific characteristics, including small dimensions and limited exudative manifestations comparing with age-related macular degeneration. However, treatment regimen and re-treatment criteria follow the PrONTO protocol. The question of the optimal dose and treatment regimen in myopic CNV management is still unresolved. There is no unequivocal evidence suggesting hat PRN treatment is more effective than a loading phase followed by an as-needed variable dosage regimen.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older then 18 years old
- •refractive error ≥ -6.0 diopters or axial length ≥ 26.0mm
- •active CNV due to high myopic which is the only reason cause visual loss confirmed by fluorescein fundus angiography
- •BCVA ≥ 24.0 and ≤73 letters at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study visual acuity chart.
排除标准
- •history of (a) stroke,(b) laser photocoagulation involved macular area in study eye, (c) intraocular treatment with corticosteroids or intraocular surgery or anti vascular endothelial growth factor or verteporfin photodynamic therapy within 6 months in study eye, or (d) hypersensitivity to ranibizumab or fluorescein
- •presence of active infectious disease or confirmed intraocular pressure ≥ 21.0 mmHg
- •pregnant or nursing women
- •uncontrolled high blood pressure ≥ 150/90 mmHg or uncontrolled fasting blood glucose ≥ 7 mmol/L
研究组 & 干预措施
Group A
Group A included 30 patients treated with one 0.5mg intravitreal ranibizumab injection. All patients were followed monthly for 12 months with additional injections performed as needed.
干预措施: 0.5mg intravitreal ranibizumab (Drug)
Group B
Group B included 30 patients treated with three monthly 0.5mg intravitreal ranibizumab injections. All patients were followed monthly for 12 months with additional injections performed as needed.
干预措施: 0.5mg intravitreal ranibizumab (Drug)
结局指标
主要结局
Injection Number
时间窗: 12 months
Total IRV injection number
Best corrected visual acuity (BCVA)
时间窗: Change from baseline to 12 months
次要结局
- Retinal sensitivities on microperimetry(Baseline and monthly after enrollment from baseline up to 12 months)
- Electrical response densities in the foveal on multifocal electroretinogram(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Alterations of optic coherence tomography angiography(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Retinal thickness on optic coherence tomography(Baseline and monthly after enrollment up to 12 months.)
- Leakage in lesion on fluorescein fundus angiography(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Fixation stability on microperimetry(Baseline and monthly after enrollment from baseline up to 12 months)
研究者
Xiaoyan Ding
Professor,PhD,MD
Zhongshan Ophthalmic Center, Sun Yat-sen University