A Multicenter Study Comparing Efficacy and Safety of " Treat-and-Extend" Regimen Versus "Pro Re Nata" Regimen of Conbercept in Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 发起方
- Xiaodong Sun
- 入组人数
- 141
- 试验地点
- 5
- 主要终点
- Mean Snellen BCVA at every visit or treatment
研究概览
简要总结
The study will evaluate the efficacy and safety of two different regimens of Conbercept (Treat-and-Extend (T&E) Regimen vs. Pro Re Nata (PRN)) in patients with wet AMD. This study is to provide long-term safety data in the treatment of patients with wet Age-related Macular Degeneration (AMD).
详细描述
Participants with wAMD were randomized and received a T&E or PRN regimen for 24 months. Mean Snellen BCVA and mean central macular thickness by OCT were examined at each visit. Any treatment-related adverse events, such as endophthalmitis, and systemic adverse events, such as stroke, were evaluated during the research.
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 active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and 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 Wet AMD (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 wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib （Macugen®），ranibizumab ,bevacizumab（Avastin®),VEGF-Trap，KH902；b）Anecortave acetate corticosteroids；c）Protein kinase C inhibitors，squalamine，siRNA; d)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
Conbercept 0.5mg Treat-and-Extend regimen
Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and optical coherence tomography (OCT) in the extension treatment period.
Intervention: Drug: Conbercept
干预措施: Treat-and-Extend regimen (Procedure)
Conbercept 0.5mg Treat-and-Extend regimen
Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and optical coherence tomography (OCT) in the extension treatment period.
Intervention: Drug: Conbercept
干预措施: Conbercept (Drug)
Conbercept 0.5mg Pro Re Nata
Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period.
Intervention: Drug: Conbercept
干预措施: Pro Re Nata (Procedure)
Conbercept 0.5mg Pro Re Nata
Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period.
Intervention: Drug: Conbercept
干预措施: Conbercept (Drug)
结局指标
主要结局
Mean Snellen BCVA at every visit or treatment
时间窗: 24 months
Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.
次要结局
- Mean number of injections after the initial three loading dose monthly injections(21 months)
- Number of participants with treatment-related adverse events(24 months)
- mean central macular thickness at every visit or treatment by OCT(24 months)
研究者
Xiaodong Sun
Professor and Executive Vicechair of Department of Ophthalmology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine