Pred Forte® versus placebo eye drops in chronic central serous chorioretinopathy trial (PICS trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in sub- and intraretinal fluid on OCT scan: The primary outcome measure of this study is the effect of steroid eye drops in cCSC on the amount of sub and intraretinal fluid. The difference in the amount of sub- and intraretinal fluid will be compared between the OCT scan made prior to the study and the OCT scan made at the second consultation after the study medication has been used for four weeks.
研究概览
简要总结
The main objective is to measure the effect of prednisolone eye drops and placebo on subretinal and intraretinal fluid in severe cCSC calculated by the cumulative areas of fluid objectified on optical coherence tomography (OCT).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 years or older Subretinal and/or intraretinal fluid on OCT and subjective visual loss or presence of Subretinal and/or intraretinal fluid for 3 months or longer Patient is able to self-administer eye drops Complex or Severe Chronic Central Serous Chorioretinopathy, with at least one of the following clinical findings that are present within the vascular arcades: Cumulative areas (>2 optic disc diameters) of diffuse atrophic RPE alterations visualized on mid-phase FA or on FAF; Multifocal "hot spots": at least 2 "hot spots" of leakage separated by at least 1 disc diameter of nonhyperfluorescent healthy-appearing retina on mid-phase FA; Diffuse leakage: an area of diffuse fluorescein leakage >1 optic disc diameter on mid-phase FA, without an evident leaking focus; Presence of posterior cystoid retinal degeneration assessed on OCT.
排除标准
- •Evidence of other retinal diagnoses: ((History of) exudative age-related macular degeneration, Suspicion of secondary choroidal neovascularization, Polypoidal choroidal vasculopathy, Multifocal choroiditis, Retinal vascular occlusions, Pseudoxanthoma elasticum, Amblyopia, Severe myopia (more than -6 diopters). Current treatment with corticosteroids or corticosteroid use within 3 months before the baseline visit Treatment with PDT, subthreshold micropulse laser or focal laser photocoagulation 6 months prior to the baseline visit. Treatment with anti-vascular endothelial growth factor (anti-VEGF), MR-antagonists or carbonic anhydrase inhibitors within 6 weeks prior to the baseline visit. If patients were treated with anti-VEGF, MR-antagonists or carbonic anhydrase inhibitors 3 months to 6 weeks prior to the baseline, patients will only be included if there was no sufficient response to treatment. Pregnant or breastfeeding women Allergy to topical ophthalmic steroids. Media opacities that prohibit detailed multimodal imaging (BCVA <20/200) (Snellen equivalent) Contraindications for fluorescein angiography or ICG angiography (known allergies especially against shellfish, previous reactions)
结局指标
主要结局
Change in sub- and intraretinal fluid on OCT scan: The primary outcome measure of this study is the effect of steroid eye drops in cCSC on the amount of sub and intraretinal fluid. The difference in the amount of sub- and intraretinal fluid will be compared between the OCT scan made prior to the study and the OCT scan made at the second consultation after the study medication has been used for four weeks.
Change in sub- and intraretinal fluid on OCT scan: The primary outcome measure of this study is the effect of steroid eye drops in cCSC on the amount of sub and intraretinal fluid. The difference in the amount of sub- and intraretinal fluid will be compared between the OCT scan made prior to the study and the OCT scan made at the second consultation after the study medication has been used for four weeks.
次要结局
未报告次要终点
研究者
Franca Christa Hartgers
Scientific
Stichting Radboud University Medical Center