Central Serous ChorioretinopathyNCT01990677
Eplerenone for the Treatment of Central Serous Chorioretinopathy
A study testing 25mg Eplerenone in people with Central Serous Chorioretinopathy, run by Wills Eye at 10 sites in United States.
Trial summary
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- 25mg Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Ability to give written informed consent
- Sub-retinal fluid under fovea seen on OCT
- Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are
- Acute- first episode or symptoms less than one month prior to presentation
- Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.
Who cannot join
- Age under 18
- Impaired decision-making ability
- At initial laboratory screening serum potassium >5.5 milliequivalent (mEq)/L
- At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
- Absence of sub-foveal fluid
- Any patient with prior treatment for CSCR within 3 months of enrollment
Show all 9Show fewer
- Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)
- Women who are pregnant or are actively trying to conceive
- Patients with type 1 or type 2 diabetes
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mid Atlantic Retina
Bala-Cynwyd, Pennsylvania, 19004
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18020
Mid Atlantic Retina
Cherry Hill, New Jersey, 08002
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, 19006
Mid Atlantic Retina
Lansdale, Pennsylvania, 19446
Mid Atlantic Retina
Marlton, New Jersey, 08053
Mid Atlantic Retina
Mays Landing, New Jersey, 08330
Mid Atlantic Retina
New Wilmington, Pennsylvania, 19803
Mid Atlantic Retina
Newtown Square, Pennsylvania, 19073
Mid Atlantic Retina
Plymouth Meeting, Pennsylvania, 19462
About this study
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
Read the detailed description
To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- 25mg Eplerenone, Placebo
- Keywords
- Central Serous Chorioretinopathy, csr, cscr, eplerenone, vision, choroid, retina, acute, chronic
- Medical subject headings
- Central Serous Chorioretinopathy, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25mg EplerenoneDrug
Also called Eplerenone, Inspra
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
PlaceboDrug
Also called Sugar pill
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Active comparator | Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. Receives: Drug: 25mg Eplerenone; Drug: Placebo |
| Placebo- Chronic CSCR Diagnosis | Placebo comparator | Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient. Receives: Drug: Placebo |
| 25mg Eplerenone- Acute CSCR Diagnosis | Active comparator | Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. Receives: Drug: 25mg Eplerenone; Drug: Placebo |
| Placebo- Acute CSCR Diagnosis. | Active comparator | Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.
Measured: Baseline and 2 months
Secondary outcomes (1)
Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Mean change in subfoveal fluid height based on spectral domain OCT measurement from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.
Measured: Baseline and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Atlantic Retina
- Responsible party
- Principal investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Mitchell Fineman, MD, Principal investigator, Mid Atlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990677
- Sponsor's protocol ID
- ECSelsior
- Other IDs
- ESCelsior2013
- Status last verified
- Oct 2018
- First submitted
- 15 Nov 2013
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 40522203
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eplerenone for the Treatment of Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01990677
- Acronym / sponsor ID
- ECSelsior
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central Serous Chorioretinopathy, csr, cscr, eplerenone, vision, choroid, retina, acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Mid Atlantic Retina
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
Detailed description
To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Active comparator | Drug: 25mg Eplerenone, Drug: PlaceboDosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. |
| Placebo- Chronic CSCR Diagnosis | Placebo comparator | Drug: PlaceboDosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient. |
| 25mg Eplerenone- Acute CSCR Diagnosis | Active comparator | Drug: 25mg Eplerenone, Drug: PlaceboDosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. |
| Placebo- Acute CSCR Diagnosis. | Active comparator | Drug: PlaceboDosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 and over
- Ability to give written informed consent
- Sub-retinal fluid under fovea seen on OCT
- Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are
Key exclusion criteria (9 listed)
- Age under 18
- Impaired decision-making ability
- At initial laboratory screening serum potassium >5.5 milliequivalent (mEq)/L
- At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
- Absence of sub-foveal fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25mg EplerenoneAlso: Eplerenone, InspraPatients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo | Drug | 25mg Eplerenone- Acute CSCR Diagnosis, 25mg Eplerenone- Chronic CSCR Diagnosis |
| PlaceboAlso: Sugar pillPatients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo. | Drug | 25mg Eplerenone- Acute CSCR Diagnosis, 25mg Eplerenone- Chronic CSCR Diagnosis, Placebo- Acute CSCR Diagnosis., Placebo- Chronic CSCR Diagnosis |
Primary outcome
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Time frame: Baseline and 2 months
Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.
1 secondary outcome
Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Time frame: Baseline and Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522203Lange 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Fineman, MD principal investigator
Mid Atlantic Retina
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25mg Eplerenone in people with Central Serous Chorioretinopathy, run by Wills Eye at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.