Clinical trial NCT01990677: Eplerenone for the Treatment of Central Serous Chorioretinopathy
Official title: Eplerenone for the Treatment of Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: Central Serous Chorioretinopathy
csr
cscr
eplerenone
vision
choroid
retina
acute
chronic
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Mid Atlantic Retina
First posted: 2013-11-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Mean Change in Subfoveal Fluid Height Based on OCT Measurement
timeFrame: Baseline and Month 2
Other outcomes:
measure: Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT
timeFrame: Baseline and Month 2
Locations:
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Marlton
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Mays Landing
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Bala-Cynwyd
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Bethlehem
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Huntingdon Valley
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Lansdale
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: New Wilmington
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Newtown Square
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
Study officials:
affiliation: Mid Atlantic Retina
name: Mitchell Fineman, MD
role: PRINCIPAL_INVESTIGATOR
References: