A Random, Open-label Multicenter, Phase IV Study Assessing the Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
试验速览
- 阶段
- 4 期
- 发起方
- Xiaodong Sun
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- PCV lesion recurrence
研究概览
简要总结
The study will evaluate the efficacy and safety of two different regimens of anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed-consent before any evaluation
- •Visual impairment due to PCV, including type 1 PCV and type 2 PCV.
- •50 years old and older
- •For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline.
排除标准
- •Have Stroke and myocardial infarction within 3 months before screening
- •Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.
- •Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers) while screening and baseline
- •Neovascularization of iris and neovascular glaucoma while screening and baseline
- •Any causes led to choroidal neovascularization except PCV (including ICNV, central serous chorioretinopathy, ocular histoplazmoza and pathologic myopia) while screening and baseline
- •With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
- •Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
- •Any medication systemic use toxic to lens, retina and optic nerve, including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
- •For study eye: Used to accept following treatments for PCV within 3 months or accept following treatments more than three times before baseline:
- •Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap;
- •Anecortave acetate corticosteroids;
- •Protein kinase C inhibitors, squalamine, siRNA;
- •PDT, Visudyne® treatment, external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
- •Any intraocular surgery (including YAG laser) within 3 months before baseline or predicated within 6 months after baseline
- •Intraocular or periocular treatment of corticosteroids within 3 months before baseline
- •For follow eye: Any anti-angiogenesis treatment (including anti-VEGF, like Lucentis, Avastin and KH902 ) within 3 months before baseline
研究组 & 干预措施
OCTA plus OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization, OCTA and OCT in the extension treatment period.
干预措施: OCTA plus OCT guided 3+PRN regimen (Procedure)
OCTA plus OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization, OCTA and OCT in the extension treatment period.
干预措施: Anti-VEGF drug (Drug)
OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization and OCT in the extension treatment period.
干预措施: OCT guided 3+PRN regimen (Procedure)
OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization and OCT in the extension treatment period.
干预措施: Anti-VEGF drug (Drug)
结局指标
主要结局
PCV lesion recurrence
时间窗: 24 months
PCV lesion recurrence is defined as the reappearance of new exudative biomakers (such as IRF, SRF, PED) or new hemorrhage detected on OCT or fundus examination in subsequent visits from the last visit showing clinical stability. PCV lesion recurrence rate will be compared at 24months between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
次要结局
- Mean central macular thickness at every visit or treatment by OCT(24 months)
- Mean Snellen BCVA at every visit or treatment(24 months)
- Number of participants with treatment-related adverse events(24 months)
- Mean number of injections after the initial three loading dose monthly injections(21 months)
研究者
Xiaodong Sun
Professor and Executive Vicechair of Department of Ophthalmology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine