Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Auxiliary Exams - Indocyanine green angiography (ICGA)
研究概览
简要总结
Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1) reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED) secondary to Polypoidal Choroidal Vasculopathy (PCV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with PCV associated with PED near the polypoidal lesion recently diagnosed, documented by FA, ICGA and OCT.
- •Visual acuity between 20/40 and 20/
- •Patients older than 50 years (both genders).
- •Women must be postmenopausal for at least 12 months or surgically sterile.
- •No previous treatment in the study eye.
- •Accept and sign the informed consent.
- •No condition that prevents the monitoring of the patient for one year.
- •Transparent ocular media and adequate pupillary dilation to allow good images of the fundus.
排除标准
- •Blepharitis or external eye infection.
- •Allergy to ranibizumab, verteporfin, triamcinolone, fluorescein or indocyanine green.
- •Patients unable to provide informed consent.
- •Concomitant ocular disease that impairs visual acuity.
- •Any intraocular condition (such as cataract or Proliferative Diabetic Retinopathy) in the study eye, in the opinion of the investigator, could require surgery or medication during the follow-up (1 year).
- •Active intraocular inflammation.
- •Patients with Glaucoma and with ocular hypertension (IOP > 25mmHg).
- •Premenopausal women. Pregnancy or lactation.
- •Effective treatment for active systemic infection or history of recurrent infection.
- •Evidence of concomitant disease (cardiovascular, neurological, pulmonary, renal, hepatic, endocrine or gastrointestinal) uncontrolled.
结局指标
主要结局
Auxiliary Exams - Indocyanine green angiography (ICGA)
时间窗: 12 months after first procedure
Indocyanine green angiography (ICGA): To Evaluate the polyp lesions regression The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
Auxiliary Exams - Optical Coherency Tomography (OCT)
时间窗: 12 months after first procedure
Optical Coherency Tomography (OCT): To Assess the Retinal Thickness using the ETDRS thickness profile and to evaluate the regression of the pigment epithelium detachment. The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
Auxiliary Exams - Fluorescein Angiography (FA)
时间窗: 12 months after first procedure
Fluorescein Angiography (FA): To Evaluate subretinal neovascularization The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
次要结局
未报告次要终点
研究者
Dr. Pedro Paulo de Oliveira Bonomo
phD
Federal University of São Paulo