Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT01822561
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eplerenone for Central Serous Chorioretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}, {'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'awitkin@tuftsmedicalcenter.org', 'phone': '6176367950', 'title': 'Andre Witkin', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study had limited enrollment due to lack of interest on the part of potential study subjects.'}}, 'adverseEventsModule': {'timeFrame': '3 months. Patients were followed for a minimum of 3 months after treatment was initiated.', 'eventGroups': [{'id': 'EG000', 'title': 'Eplerenone Group', 'description': 'All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shortness of breath', 'notes': 'One patient stopped treatment after 2 weeks because of subjective shortness of breath. Symptoms resolved within 1 day of stopping the medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'notes': 'One patient stopped treatment after experiencing subjective headache and heart palpitations after a single dose. Symptoms resolved within 1 day of stopping the medication.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Resolution of Subretinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients That Took Eplerenone', 'description': 'Patients received 50mg oral eplerenone daily for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Optical coherence tomography is an imaging technique capable of extremely high resolution (\\~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Macular Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients That Received Eplerenone', 'description': 'Patients took 50mg oral eplerenone daily for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '-26', 'spread': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.', 'unitOfMeasure': 'Microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Best Corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients That Took Eplerenone', 'description': 'Patients received oral Eplerenone 50mg once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Subfoveal Choroidal Thickness, Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients That Received Eplerenone', 'description': 'Patients received oral Eplerenone 50mg once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients That Received Eplerenone', 'description': 'Patients took oral Eplerenone 50mg once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eplerenone Group', 'description': 'All patients in this study received Eplerenone 50mg once daily for 4 weeks.\n\nEplerenone 50mg: All patients received the same dose of eplerenone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '15', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'One eye from each subject was used', 'recruitmentDetails': 'Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CSCR Patients Who Received Eplerenone', 'description': 'All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patients with chronic CSCR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2 Acute CSCR, 11 Chronic CSCR'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-04-10', 'size': 333888, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-16T16:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2013-03-25', 'resultsFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-17', 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Resolution of Subretinal Fluid', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Optical coherence tomography is an imaging technique capable of extremely high resolution (\\~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy'}], 'secondaryOutcomes': [{'measure': 'Change in Macular Thickness', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.'}, {'measure': 'Change in Best Corrected Visual Acuity', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)'}, {'measure': 'Change in Subfoveal Choroidal Thickness, Study Eye', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.'}, {'measure': 'Change in Serum Potassium', 'timeFrame': 'Baseline and 1 month after treatment', 'description': 'Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Central Serous Chorioretinopathy', 'Eplerenone', 'Optical Coherence Tomography', 'Enhanced Depth Imaging', 'Subretinal Fluid'], 'conditions': ['Central Serous Chorioretinopathy']}, 'referencesModule': {'references': [{'pmid': '22684104', 'type': 'BACKGROUND', 'citation': 'Zhao M, Celerier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.'}, {'pmid': '20930852', 'type': 'BACKGROUND', 'citation': 'Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.'}, {'pmid': '12431693', 'type': 'BACKGROUND', 'citation': 'Bouzas EA, Karadimas P, Pournaras CJ. Central serous chorioretinopathy and glucocorticoids. Surv Ophthalmol. 2002 Sep-Oct;47(5):431-48. doi: 10.1016/s0039-6257(02)00338-7.'}, {'pmid': '18538401', 'type': 'BACKGROUND', 'citation': 'Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.'}, {'pmid': '19898183', 'type': 'BACKGROUND', 'citation': 'Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.'}, {'pmid': '19896635', 'type': 'BACKGROUND', 'citation': 'Reibaldi M, Cardascia N, Longo A, Furino C, Avitabile T, Faro S, Sanfilippo M, Russo A, Uva MG, Munno F, Cannemi V, Zagari M, Boscia F. Standard-fluence versus low-fluence photodynamic therapy in chronic central serous chorioretinopathy: a nonrandomized clinical trial. Am J Ophthalmol. 2010 Feb;149(2):307-315.e2. doi: 10.1016/j.ajo.2009.08.026. Epub 2009 Nov 6.'}, {'pmid': '6682293', 'type': 'BACKGROUND', 'citation': 'Robertson DM, Ilstrup D. Direct, indirect, and sham laser photocoagulation in the management of central serous chorioretinopathy. Am J Ophthalmol. 1983 Apr;95(4):457-66. doi: 10.1016/0002-9394(83)90265-9.'}, {'pmid': '21878843', 'type': 'BACKGROUND', 'citation': 'Nielsen JS, Jampol LM. Oral mifepristone for chronic central serous chorioretinopathy. Retina. 2011 Oct;31(9):1928-36. doi: 10.1097/IAE.0b013e31821c3ef6.'}, {'pmid': '21273946', 'type': 'BACKGROUND', 'citation': 'Forooghian F, Meleth AD, Cukras C, Chew EY, Wong WT, Meyerle CB. Finasteride for chronic central serous chorioretinopathy. Retina. 2011 Apr;31(4):766-71. doi: 10.1097/IAE.0b013e3181f04a35.'}, {'pmid': '12160194', 'type': 'BACKGROUND', 'citation': 'Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens. 2002 Aug;15(8):709-16. doi: 10.1016/s0895-7061(02)02957-6.'}, {'pmid': '12668699', 'type': 'BACKGROUND', 'citation': 'Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. doi: 10.1056/NEJMoa030207. Epub 2003 Mar 31.'}, {'pmid': '18394706', 'type': 'RESULT', 'citation': 'Fujimoto H, Gomi F, Wakabayashi T, Sawa M, Tsujikawa M, Tano Y. Morphologic changes in acute central serous chorioretinopathy evaluated by fourier-domain optical coherence tomography. Ophthalmology. 2008 Sep;115(9):1494-500, 1500.e1-2. doi: 10.1016/j.ophtha.2008.01.021. Epub 2008 Apr 18.'}, {'pmid': '31516734', 'type': 'DERIVED', 'citation': 'Moein HR, Bierman LW, Novais EA, Moreira-Neto C, Baumal CR, Rogers A, Duker JS, Witkin AJ. Short-term eplerenone for treatment of chronic central serous chorioretinopathy; a prospective study. Int J Retina Vitreous. 2019 Sep 9;5:39. doi: 10.1186/s40942-019-0190-y. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "* The goal of the study is to examine the short-term effects and safety of a systemic anti-aldosterone medication, eplerenone, in a small group of patients with central serous chorioretinopathy (CSCR).\n* There is currently no standard treatment or therapy for either acute or chronic CSCR, a potentially debilitating eye disease.\n* There is evidence in both animals and humans that high blood serum corticosteroid levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina\n* Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR\n* The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for both acute and chronic CSCR.\n* The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1 month\n* Over the course of the month, patients will be monitored for side effects, as well as visual and anatomical response to the medication", 'detailedDescription': '* The investigators hypothesize that aldosterone inhibition with eplerenone will decrease choroidal vessel vasodilation, focal leakage, and choroidal thickness in patients with both acute and chronic CSCR, leading to resolution of subretinal fluid and ultimately an improvement in symptoms.\n* Resolution of sub-retinal fluid will be the primary outcome, which can be precisely measured using optical coherence tomography (OCT)\n* Secondary outcomes will include: Change in macular thickness measured with OCT, in central macular circle thickness on OCT, change in visual acuity, change in dye leakage characteristics on fluorescein angiography, change in OCT characteristics of the fellow eye, and safety and tolerability characteristics\n* In acute CSCR, subretinal fluid often resolves on its own, but it often takes several months (the literature shows that \\~20% of patients have complete resolution of sub-retinal fluid on OCT 1 month after presentation)\n* Chronic CSCR is defined as persistent fluid on OCT after 3 months of symptom onset, or recurrence of signs and symptoms within 1 year after the prior episode\n* In this study, the investigators will not make a distinction between acute and chronic CSCR\n* Eplerenone, a generic medication, is a potassium sparing diuretic, which is FDA approved to treat heart failure as well as high blood pressure, but is not FDA approved for treatment of central serous chorioretinopathy.\n* The most important side effect of eplerenone is elevation of serum potassium and decrease of blood pressure\n* Patients will therefore be screened with routine blood tests as suggested by the package insert of the medication, and serum potassium and blood pressure will be monitored routinely as directed by the medication package insert\n* Study visits will be performed at therapy initiation, 1 week, 2 weeks, and 4 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or over\n2. Ability to give written informed consent\n3. Presence of sub-retinal fluid under the fovea as seen on OCT\n4. Diagnosis of Acute or Chronic CSCR:\n\n * Acute CSCR: First presentation to eye clinic with visual symptoms, including decreased vision or visual distortion, and the characteristic appearance of CSCR on examination, fluorescein angiography, and OCT.\n * Chronic CSCR: Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 3 months after initial presentation to the eye clinic, and \\<50% reduction in fluid thickness on OCT after 3 months. Patients who have had previous treatment for CSCR may be included.\n\nExclusion Criteria:\n\n1. Age less than 18\n2. Persons with impaired decision-making ability.\n3. Women who are known to be pregnant or are actively trying to conceive.\n4. Additional eye disease affecting the macula or posterior retina.\n5. At screening, serum potassium concentration ≥5.0 mEq/L , a serum creatinine concentration \\>2 mg/dL in men and \\>1.8 mg/dL in women, or a creatinine clearance \\<50 mL/min, and during concomitant administration of potassium supplements, potassium-sparing diuretics, and/or potent CYP3A4 inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, Rituximab, tacrolimus or voriconazole).\n6. Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.'}, 'identificationModule': {'nctId': 'NCT01822561', 'briefTitle': 'Eplerenone for Central Serous Chorioretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Eplerenone for Central Serous Chorioretinopathy: A Pilot Study', 'orgStudyIdInfo': {'id': 'NEEC-10722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone', 'description': 'All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.', 'interventionNames': ['Drug: Eplerenone 50mg']}], 'interventions': [{'name': 'Eplerenone 50mg', 'type': 'DRUG', 'otherNames': ['Inspra (Pfizer)', 'Eplerenone (Generic)'], 'description': 'All patients will receive the same dose of eplerenone.', 'armGroupLabels': ['Eplerenone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Eye Center / Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Andre J Witkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}