Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Mar 8, 2017

Keywords

ClinConnect Summary

Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.

To date there is no international consensus on the optimal treatment of...

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Eligibility criteria

• Inclusion Criteria:
• • Age of ≥ 18 years of age and able to give written informed consent;
• • Active chronic central serous chorioretinopathy (cCSC);
• • Subjective visual loss \> 6 weeks, interpreted as onset of active disease;
• • Foveal subretinal fluid (SRF), on optical coherence tomography (OCT), at Baseline Examination;
• • ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with retinal pigment epithelial window defect(s) that are compatible with cCSC;
• • Hyperfluorescent areas on indocyanine green angiography (ICGA).
• Exclusion Criteria:
• • 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;
• • Best-corrected visual acuity \< 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 photodynamic 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.