Central Serous Chorioretinitis | Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Central Serous Chorioretinitis research study
What is the primary objective of this study?
The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients. CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR. Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow. The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR. Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters
Who is eligible to participate?
Inclusion Criteria: - Patient between 18 and 60 years - CSCR affecting the macula and non-resolutive for at least 3 months - Patients having given and signed informed consent - Vital prognosis non engaged for the next 6 months. Exclusion Criteria: - Other ocular pathology - Neovascularization, - Diabetes - Uveitis - Ocular surgery in the last 3 months - Allergy to fluorescein or indocyanine green - Pregnancy or no contraception - Renal or liver insufficiency - Kaliemia ≥ 5.5 mmol/l Criteria of efficacy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Central Serous Chorioretinitis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Spironolactone25mg tablet once a day for 1 month
Drug:Placeboone tablet once a day for 1 month
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2012
Completed Date: February 2013
Phase: Phase 1/Phase 2
Primary Outcome: Change in Central macular thickness
Study sponsors, principal investigator, and references
Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France