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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003046-40 | EudraCT Number |
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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
This is a prospective placebo controlled cross over study including 16 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spironolactone | Experimental | Spironolactone 25mg/day |
|
| Placebo | Placebo Comparator | placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | 25mg tablet once a day for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central macular thickness | Sub retinal fluid decrease > or = 40 microns | 1 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel-Dieu of Paris | Paris | 75004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26017871 | Result | Bousquet E, Beydoun T, Rothschild PR, Bergin C, Zhao M, Batista R, Brandely ML, Couraud B, Farman N, Gaudric A, Chast F, Behar-Cohen F. SPIRONOLACTONE FOR NONRESOLVING CENTRAL SEROUS CHORIORETINOPATHY: A RANDOMIZED CONTROLLED CROSSOVER STUDY. Retina. 2015 Dec;35(12):2505-15. doi: 10.1097/IAE.0000000000000614. | |
| 40522203 | Derived |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Drug | one tablet once a day for 1 month |
|
| Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3. |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |