A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROL PILOT STUDY OF EPLERENONE FOR THE TREATMENT OF CENTRAL SEROUS CHORIORETINOPATHY (ECSELSIOR)
Autor: | Wasim A. Samara, James F. Vander, Abtin Shahlaee, Mitchell S. Fineman, John D. Pitcher, Marc J. Spirn, Ehsan Rahimy, Murtaza K. Adam, Jason Hsu, Richard S. Kaiser, Allen Chiang |
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Rok vydání: | 2018 |
Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty endocrine system diseases Referral Visual Acuity Administration Oral Pilot Projects Spironolactone Placebo Retina law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Prospective Studies Prospective cohort study Aged Mineralocorticoid Receptor Antagonists business.industry Subretinal Fluid General Medicine Middle Aged Eplerenone Surgery Ophthalmology Serous fluid 030104 developmental biology Central Serous Chorioretinopathy chemistry Private practice Chronic Disease 030221 ophthalmology & optometry Female business medicine.drug |
Zdroj: | Retina. 38:962-969 |
ISSN: | 0275-004X |
DOI: | 10.1097/iae.0000000000001649 |
Popis: | To evaluate the safety and effects of oral eplerenone in chronic central serous chorioretinopathy.Prospective, randomized, double-blind, placebo-control study at a tertiary referral academic private practice. For a diagnosis of chronic central serous chorioretinopathy, patients must have had at least 3 months clinical follow-up demonstrating persistent symptoms, subfoveal fluid on spectral-domain optical coherence tomography, and50% reduction in fluid thickness. Patients were randomized 2:1 (treatment:placebo) to receive eplerenone (25 mg daily for 1 week, then up to 50 mg daily for 8 weeks) or placebo once daily.Fifteen patients completed the study. Ten patients (15 eyes) were randomized into the eplerenone treatment arm, while the remaining 5 patients (6 eyes) received placebo. After 9 weeks of eplerenone therapy, mean logarithm of the minimal angle of resolution visual acuity improved from 0.394 (Snellen equivalent: 20/50) to 0.330 (20/43, P = 0.04). In the placebo group, the mean logarithm of the minimal angle of resolution visual acuity slightly decreased from 0.313 (20/41) to 0.342 (20/44) during the same period (P = 0.21). With respect to anatomic changes, mean maximal subretinal fluid height in the eplerenone group improved from 139.3 μm at baseline to 51.8 μm (P = 0.02), mean subfoveal fluid height improved from 121.4 μm to 29.4 μm (P = 0.01), and mean central subfield thickness improved from 366.2 μm to 283.7 μm (P = 0.02). In comparison with the placebo group, mean maximal subretinal fluid height worsened from 135.9 μm to 172.3 μm (P = 0.32), mean subfoveal fluid height worsened from 92.1 μm to 134.0 μm (P = 0.54), and mean central subfield thickness worsened from 345.0 μm to 380.0 μm (P = 0.37). No patients in either group experienced serious adverse events to result in treatment discontinuation.These findings suggest that oral eplerenone therapy is safe and potentially effective in the treatment of chronic central serous chorioretinopathy with persistent subretinal fluid. |
Databáze: | OpenAIRE |
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