Tina Rike Herold1,2,3, Kristina Rist4,5,6, Siegfried Georg Priglinger4,5,6, Michael Werner Ulbig7, Armin Wolf4,5,6. 1. University Eye Hospital - LMU, 80539, Munich, Germany. Tina.Herold@med.uni-muenchen.de. 2. Department of Ophthalmology, Ludwig-Maximilians Universität, 80539, Munich, Germany. Tina.Herold@med.uni-muenchen.de. 3. Klinikum der Universität München, Campus Innenstadt, Mathildenstrasse 8, D-80336, Munich, Germany. Tina.Herold@med.uni-muenchen.de. 4. University Eye Hospital - LMU, 80539, Munich, Germany. 5. Department of Ophthalmology, Ludwig-Maximilians Universität, 80539, Munich, Germany. 6. Klinikum der Universität München, Campus Innenstadt, Mathildenstrasse 8, D-80336, Munich, Germany. 7. Klinik und Poliklinik für Augenheilkunde, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Straße 22, D-81675, Munich, Germany.
Abstract
PURPOSE: To evaluate the long-term results of spironolactone in non-resolving central serous chorio-retinopathy (CSCR) and recurrence rates of CSCR. METHODS: Interventional uncontrolled open-label prospective clinical trial of patients with non-resolving CSCR who were treated withspironolactone 50 mg daily (Spironolacton AL® 50 mg, ALIUD PHARMA) for up to 16 weeks. Follow-up visits were performed at 3, 6, 9, and 12 months. Retreatment criteria for recurrence were: gain in sub-retinal fluid (SRF) of more than 25 % plus/or increase of central retinal thickness (CRT) of more than 50 μm plus visual symptoms compared to last visit. MAIN OUTCOME MEASURES: 12-month efficacy of upload treatment with spironolactone. Secondary outcome measure was the recurrence rate at 6, 9, and 12 months. RESULTS: Of the 21 study eyes treated, 71 % (n = 15) showed significant improvement or complete regression on OCT examination over 12 months. Nineteen percent of the patients (n = 4) showed a stable course from visit 1 to visit 12. The overall reduction of sub-retinal fluid from visit 1 (156 μm ± 131 SD) to visit 12 (53 μm ± 93 SD) was statistically significant (p = 0.003). The change of mean visual acuity (log MAR) from 0.25 (± 0.17 SD) at baseline to 0.17 (± 0.18 SD) at visit 12 was statistically significant, with p = 0.044. CONCLUSION: Our results confirm a positive effect of spironolactone in non-resolving CSCR in 71 % of cases. Evaluation of recurrence rates and retreatments showed good results in patients who responded to spironolactone primarily. A prospective randomized trial may provide better data about this non-invasive treatment.
RCT Entities:
PURPOSE: To evaluate the long-term results of spironolactone in non-resolving central serous chorio-retinopathy (CSCR) and recurrence rates of CSCR. METHODS: Interventional uncontrolled open-label prospective clinical trial of patients with non-resolving CSCR who were treated with spironolactone 50 mg daily (Spironolacton AL® 50 mg, ALIUD PHARMA) for up to 16 weeks. Follow-up visits were performed at 3, 6, 9, and 12 months. Retreatment criteria for recurrence were: gain in sub-retinal fluid (SRF) of more than 25 % plus/or increase of central retinal thickness (CRT) of more than 50 μm plus visual symptoms compared to last visit. MAIN OUTCOME MEASURES: 12-month efficacy of upload treatment with spironolactone. Secondary outcome measure was the recurrence rate at 6, 9, and 12 months. RESULTS: Of the 21 study eyes treated, 71 % (n = 15) showed significant improvement or complete regression on OCT examination over 12 months. Nineteen percent of the patients (n = 4) showed a stable course from visit 1 to visit 12. The overall reduction of sub-retinal fluid from visit 1 (156 μm ± 131 SD) to visit 12 (53 μm ± 93 SD) was statistically significant (p = 0.003). The change of mean visual acuity (log MAR) from 0.25 (± 0.17 SD) at baseline to 0.17 (± 0.18 SD) at visit 12 was statistically significant, with p = 0.044. CONCLUSION: Our results confirm a positive effect of spironolactone in non-resolving CSCR in 71 % of cases. Evaluation of recurrence rates and retreatments showed good results in patients who responded to spironolactone primarily. A prospective randomized trial may provide better data about this non-invasive treatment.
Entities:
Keywords:
Central serous retinopathy; Recurrence; Spironolactone; Subretinal fluid
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