Eplerenone for the Treatment of Central Serous Chorioretinopathy

NCT01990677 | Completed Results

• 2 other identifiers: ECSelsiorESCelsior2013
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 10

Brief Summary

To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Conditions

Central Serous Chorioretinopathy

Keywords

Central Serous Chorioretinopathy; csr; cscr; eplerenone; vision; choroid; retina; acute; chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 months

Secondary Outcomes (1)

• Mean Change in Subfoveal Fluid Height Based on OCT Measurement

  Baseline and Month 2

Other Outcomes (1)

• Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT

  Baseline and Month 2

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo

Interventions

25mg Eplerenone DRUG

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

Also known as: Eplerenone, Inspra

25mg Eplerenone- Acute CSCR Diagnosis; 25mg Eplerenone- Chronic CSCR Diagnosis

Placebo DRUG

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.

Also known as: Sugar pill

25mg Eplerenone- Acute CSCR Diagnosis; 25mg Eplerenone- Chronic CSCR Diagnosis; Placebo- Acute CSCR Diagnosis.; Placebo- Chronic CSCR Diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wills Eye: lead
• Mid Atlantic Retina: collaborator

Study Sites (10)

Mid Atlantic Retina

Cherry Hill, New Jersey, 08002, United States

Location

Mid Atlantic Retina

Marlton, New Jersey, 08053, United States

Location

Mid Atlantic Retina

Mays Landing, New Jersey, 08330, United States

Location

Mid Atlantic Retina

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Mid Atlantic Retina

Bethlehem, Pennsylvania, 18020, United States

Location

Mid Atlantic Retina

Huntingdon Valley, Pennsylvania, 19006, United States

Location

Mid Atlantic Retina

Lansdale, Pennsylvania, 19446, United States

Location

Mid Atlantic Retina

New Wilmington, Pennsylvania, 19803, United States

Location

Mid Atlantic Retina

Newtown Square, Pennsylvania, 19073, United States

Location

Mid Atlantic Retina

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Related Publications (1)

• 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.

  PMID: 40522203 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy; Bronchiolitis Obliterans Syndrome

Interventions

Eplerenone; Sugars

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Mitchell Fineman,MD
• Organization: Wills Eye

research@midatlanticretina.com

215-928-3092

Study Officials

• Mitchell Fineman, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mitchell Fineman

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 7, 2018
• Results First Posted: June 29, 2017

Record last verified: 2018-10

Locations

US (10)