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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone | Experimental | All patients in this study will receive Eplerenone 50mg once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone 50mg | Drug | All patients will receive the same dose of eplerenone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Resolution of Subretinal Fluid | 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 | Baseline and 1 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Macular Thickness | 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. | Baseline and 1 month after treatment |
| Change in Best Corrected Visual Acuity |
Not provided
Inclusion Criteria:
Age 18 or over
Ability to give written informed consent
Presence of sub-retinal fluid under the fovea as seen on OCT
Diagnosis of Acute or Chronic CSCR:
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Andre J Witkin, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Eye Center / Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22684104 | Background | 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. | |
| 20930852 | Background | 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. |
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Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.
| ID | Title | Description |
|---|---|---|
| FG000 | Eplerenone Group | All patients in this study received Eplerenone 50mg once daily for 4 weeks. Eplerenone 50mg: All patients received the same dose of eplerenone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 Acute CSCR, 11 Chronic CSCR
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CSCR Patients Who Received Eplerenone | All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Resolution of Subretinal Fluid | 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 | Posted | Number | participants | Baseline and 1 month after treatment |
|
|
3 months. Patients were followed for a minimum of 3 months after treatment was initiated.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eplerenone Group | All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One patient stopped treatment after 2 weeks because of subjective shortness of breath. Symptoms resolved within 1 day of stopping the medication. |
The study had limited enrollment due to lack of interest on the part of potential study subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andre Witkin | Tufts Medical Center | 6176367950 | awitkin@tuftsmedicalcenter.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2013 | Apr 16, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
Not provided
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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) |
| Baseline and 1 month after treatment |
| Change in Subfoveal Choroidal Thickness, Study Eye | 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. | Baseline and 1 month after treatment |
| Change in Serum Potassium | Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline. | Baseline and 1 month after treatment |
| 12431693 | Background | 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. |
| 18538401 | Background | 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. |
| 19898183 | Background | 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. |
| 19896635 | Background | 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. |
| 6682293 | Background | 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. |
| 21878843 | Background | Nielsen JS, Jampol LM. Oral mifepristone for chronic central serous chorioretinopathy. Retina. 2011 Oct;31(9):1928-36. doi: 10.1097/IAE.0b013e31821c3ef6. |
| 21273946 | Background | 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. |
| 12160194 | Background | 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. |
| 12668699 | Background | 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. |
| 18394706 | Result | 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. |
| 31516734 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patients with chronic CSCR | Count of Participants | Participants |
|
|
| Secondary | Change in Macular Thickness | 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. | Posted | Mean | Standard Deviation | Microns | Baseline and 1 month after treatment |
|
|
|
| Secondary | Change in Best Corrected Visual Acuity | 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) | Posted | Mean | Standard Deviation | logMAR | Baseline and 1 month after treatment |
|
|
|
| Secondary | Change in Subfoveal Choroidal Thickness, Study Eye | 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. | Posted | Mean | Standard Deviation | microns | Baseline and 1 month after treatment |
|
|
|
| Secondary | Change in Serum Potassium | Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline. | Posted | Mean | Standard Deviation | mEq/L | Baseline and 1 month after treatment |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
|
| Palpitations | Cardiac disorders | Systematic Assessment | One patient stopped treatment after experiencing subjective headache and heart palpitations after a single dose. Symptoms resolved within 1 day of stopping the medication. |
|
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004364 | Pharmaceutical Preparations |