NCT05229237已完成不适用
A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
- To evaluate the effectiveness of Conbercept for PCV patients.
- To describe the characteristics of PCV.
- To describe the adverse events (AE) of Conbercept in the treatment of PCV.
- Todescirbe the real situation and prognosis of PCV patients in our country.
详细描述
- To observe the visual changes in PCV patients receiving Conbercept treatment, so as to evaluate the effectiveness of the treatment. Changes of OCT, ICGA, quality of life and visual function would be observed and evaluated.
- To observe and describe the characteristics of PCV.
- To observe and describe the incidence of adverse events (AE) and serious adverse events (SAE) of Conbercept in the treatment of PCV, so as to evaluate the safety of this treatment.
- To observe and descirbe the real situation and prognosis of PCV patients in our country.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •According to the current diagnostic criteria, diagnosed as PCV patients
- •Conbercept is used for treatment, and the recommended treatment scheme is 3+PRN
- •Local and systemic anti-VEGF therapy was not used for at least three months before enrollment
- •The patient volunteers to take part in this observational study, and signs the informed consent
- •The patient can follow-up regularly (at least 4 times of follow-up in one year)
排除标准
- •The patient has serious systemic disease, and the current clinical treatment is contraindicated
- •Local or systemic anti-VEGF therapy was used for less than three months before enrollment
- •Existence of diseases unsuitable to accept intravitreal Conbercept, including uncontrolled hypertension and diabetes, AIDS, malignant tumors, active hepatitis, severe renal failure, severe mental, nerve, cardiovascular, respiratory and immune diseases
- •During six months before screening, there were cardiovascular events such as stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure
- •Ocular contraindications, including active intraocular inflammation, infectious endophthalmitis, corneal ulcer, scleritis, uncontrolled glaucoma and so on
- •Patients who could not follow up regularly
- •Patients who refuse to sign the informed consent
结局指标
主要结局
Visual acuity
时间窗: 6 months after the first Conbercept treatment
Best corrected visual acuity using ETDRS chart (letter numbers)
次要结局
- FFA&ICGA(12 months after the first Conbercept treatment)
- OCT and OCTA(12 months after the first Conbercept treatment)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Assessment of the Effectiveness and Safety Outcome in Patients With Atrial Fibrillation Treated by Apixaban in BelgiumAtrial FibrillationNCT05116267Pfizer
已完成
不适用
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue ReconstructionFull-thickness Skin DefectsDegloving InjuriesCrush InjuriesLaceration of SkinSurgical WoundInfectionGun Shot WoundCellulitisSkin CancerNecrotizing FasciitisNCT04091672Avita Medical65
终止
不适用
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component SeparationHerniaNCT01305486C. R. Bard4
已完成
不适用
Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical PracticeHIV InfectionsNCT03042390Fundacion SEIMC-GESIDA762
终止
不适用
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg UlcersVenous Stasis UlcerNCT01612806Integra LifeSciences Corporation31