NL-OMON50407已完成4 期
Study on half-dose Photodynamic therapy versus Eplerenone in chronic CenTRAl serous chorioretinopathy (SPECTRA trial) - SPECTRA trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •This study will enroll subjects with chronic central serous chorioretinopathy
- •(cCSC) with active leakage of fluid to under the retina as evidenced on optical
- •coherence tomography (OCT) scanning and further supported by findings on
- •fluorescein angiography (FA) and indocyanine green angiography (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 for more then 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 less then 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
- •- Age of >= 18 years of age and able to give written informed consent;
- •- Active cCSC;
- •- Subjective visual loss for more then 6 weeks, interpreted as onset of active
- •- Foveal subretina fluid on OCT, at Baseline Examination;
- •- >=1 ill-defined hyperfluorescent leakage areas on FA with retinal pigment
- •epithelial window defect(s) that are compatible with cCSC;
- •- Hyperfluorescent areas on ICGA.Bá*CBC
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
- •- 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
- •- (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.BKKá*J
研究者
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