Central Serous Chorioretinitis Clinical Trial
Official title:
Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois
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
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | February 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hotel-Dieu of Paris | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Central macular thickness | Sub retinal fluid decrease > or = 40 microns | 1 and 3 months | No |