EUCTR2016-004119-11-NL进行中（未招募）1 期
Study on half-dose Photodynamic therapy versus Eplerenone in chronic CenTRAl serous chorioretinopathy (SPECTRA trial) - SPECTRA
eiden University Medical Center0 个研究点开始时间: 2016年11月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •This study will enroll subjects with cCSC with active leakage of fluid to under the retina as evidenced on OCT scanning and further supported by findings on FA and ICGA, in at least 1 eye, who visit the outpatient clinic of the Department of Ophthalmology of the Radboud University Medical Center, the Academic Medical Center Amsterdam, or the Leiden University Medical Center. If both eyes are eligible, then the eye with the longer duration of disease will be used as the study eye, except in cases where the disease is present > 18 months. In the latter case, which is an exclusion criterion, the other eye will be eligible for inclusion if the disease is active for < 18 months in that eye. If the non-study eye also has active disease, the choice to treat and the type of treatment in this eye may be chosen freely at the discretion of the responsible ophthalmologist.
- •Before enrolment, each subject must meet all of the following inclusion criteria and none of the exclusion criteria, and agree to comply with the study requirements including completion of all of the study visits.
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- Age of = 18 years of age and able to give written IC;
- •- Active cCSC;
- •- Subjective visual loss > 6 weeks, interpreted as onset of active disease;
- •- Foveal SRF on OCT, at Baseline Examination;
- •- =1 ill-defined hyperfluorescent leakage areas on FA with RPE window defect(s) that are compatible with cCSC;
- •- Hyperfluorescent areas on ICGA.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •A potential subject who meets any of the following criteria for the study eye will be excluded from participation in this study:
- •- Any previous treatments for active CSC;
- •- Previous prescription of mineralocorticoid receptor antagonists, for cCSC or for other diseases;
- •- Current treatment with corticosteroids (topical or systemic), corticosteroid use within 3 months before possible start of trial treatment, or anticipated start of corticosteroid treatment within the first 2 years from the start of the trial period;
- •- Evidence of another diagnosis that can explain serous SRF or visual loss;
- •- BCVA < 20/200 (Snellen equivalent);
- •- Profound chorioretinal atrophy in central macular area on ophthalmoscopy and OCT;
- •- Myopia > 6D;
- •- Visual loss and/or serous detachment on OCT < 6 weeks;
- •- Continuous and/or progressive visual loss > 18 months or serous detachment on OCT > 18 months;
- •- No hyperfluorescence on ICGA;
- •- Intraretinal edema on OCT;
- •- (relative) Contraindications for FA or ICGA;
- •- (relative) Contraindications for PDT treatment (pregnancy, porphyria, severely disturbed liver function). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening;
- •- (relative) Known contraindications for initiation of eplerenone treatment (hyperkalemia, abnormal renal clearance, severe hepatic insufficiency (Child-Pugh C), type 2 diabetes mellitus with microalbuminuria, concomitant use of potassium supplements, potassium-sparing diuretics, strong CYP3A4 inhibitors, or the combination of an ACE-inhibitor and an angiotensin receptor blocking agent). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening;
- •- Soft drusen in treated eye or fellow eye, signs of choroidal neovascularization on ophthalmoscopy and/or FA/ICGA of the study eye.
- •The previous prescription of oral medication (for example, acetazolamide) for cCSC, except the prescription of previous mineralocorticoid receptor antagonists, is not an exclusion criterion for this study.
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