Brief Title
Methotrexate for Central Serous Chorioretinopathy Treatment Trial
Official Title
Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy
Brief Summary
Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple
reports have indicated correlation of appearance of CSC with exposure to exogenous or
elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids
is upregulated in many inflammatory conditions, control of the inflammation may be beneficial
in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely
used to control different types of inflammation. The investigators are going to try an
escalating doses of MTX to treat CSC under full medical supervision.
Detailed Description
Central serous chorioretinopathy (CSC) is a disease of unknown origin usually affecting the
center of the macula in adults of working age. Though previously the condition was considered
stress-related, multiple recent reports have indicated correlation of appearance of CSC with
exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of
endogenous corticosteroids is upregulated in many inflammatory conditions, control of the
inflammation may downregulate the endogenous steroids thus eliminating the stimulus for CSC.
Methotrexate (MTX) is widely used to control different types of inflammation. Few short
retrospective series of beneficial effect of MTX on CSC were reported recently. The
investigators are going to try an escalating doses of MTX to treat CSC under full medical
supervision in a prospective manner.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Optical Coherence Tomography indicating the level of central serous detachment
Condition
Central Serous Chorioretinopathy
Intervention
Methotrexate
Study Arms / Comparison Groups
Methotrexate
Description: Chronic CSC will be given an immediate MTX treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
August 2012
Completion Date
July 2015
Primary Completion Date
July 2014
Eligibility Criteria
Inclusion Criteria:
- Central Serous Chorioretinopathy
Exclusion Criteria:
- Pregnancy
- Liver disease
- Kidney disease
- Steroid use
Gender
All
Ages
20 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Edward Averbukh, MD, ,
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT01633983
Organization ID
khateb-HMO-CTIL
Responsible Party
Sponsor-Investigator
Study Sponsor
Edward Averbukh
Study Sponsor
Edward Averbukh, MD, Principal Investigator, Hadassah Medical Organization
Verification Date
July 2012