Methotrexate for Central Serous Chorioretinopathy Treatment Trial

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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