Eplerenone for the Treatment of Central Serous Chorioretinopathy

NCT ID: NCT01990677

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-05-31

Brief Summary

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).

Conditions

Central Serous Chorioretinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

25mg Eplerenone- Chronic CSCR Diagnosis

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.

Group Type: ACTIVE_COMPARATOR

25mg Eplerenone

Intervention Type: 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

Placebo

Intervention Type: 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.

Placebo- Chronic CSCR Diagnosis

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

25mg Eplerenone- Acute CSCR Diagnosis

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.

Group Type: ACTIVE_COMPARATOR

25mg Eplerenone

Intervention Type: 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

Placebo

Intervention Type: 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.

Placebo- Acute CSCR Diagnosis.

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

25mg Eplerenone

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

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Eplerenone; Inspra; Sugar pill

Eligibility Criteria

Inclusion Criteria

• 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

1. Acute- first episode or symptoms less than one month prior to presentation

2. 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mid Atlantic Retina

OTHER

Sponsor Role: collaborator

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

MidAtlantic Retina

Dr. Mitchell Fineman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell Fineman, MD

Role: PRINCIPAL_INVESTIGATOR

Mid Atlantic Retina

Locations

Mid Atlantic Retina

Cherry Hill, New Jersey, United States

Mid Atlantic Retina

Marlton, New Jersey, United States

Mid Atlantic Retina

Mays Landing, New Jersey, United States

Mid Atlantic Retina

Bala-Cynwyd, Pennsylvania, United States

Mid Atlantic Retina

Bethlehem, Pennsylvania, United States

Mid Atlantic Retina

Huntingdon Valley, Pennsylvania, United States

Mid Atlantic Retina

Lansdale, Pennsylvania, United States

Mid Atlantic Retina

New Wilmington, Pennsylvania, United States

Mid Atlantic Retina

Newtown Square, Pennsylvania, United States

Mid Atlantic Retina

Plymouth Meeting, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40522203 (View on PubMed)

Other Identifiers

ESCelsior2013

Identifier Type: OTHER

Identifier Source: secondary_id

ECSelsior

Identifier Type: -

Identifier Source: org_study_id