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Trial record 2 of 57 for:    "Central serous chorioretinopathy"

Methotrexate for Central Serous Chorioretinopathy Treatment Trial (MTX4CSC)

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ClinicalTrials.gov Identifier: NCT01633983
Recruitment Status : Unknown
Verified July 2012 by Edward Averbukh, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Edward Averbukh, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE July 2, 2012
First Posted Date  ICMJE July 6, 2012
Last Update Posted Date July 20, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
Optical Coherence Tomography indicating the level of central serous detachment [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01633983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Methotrexate for Central Serous Chorioretinopathy Treatment Trial
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Central Serous Chorioretinopathy
Intervention  ICMJE
  • Drug: Methotrexate
    7.5 mg per week p.o. escalating up to 15 mg per week
  • Drug: Delayed treatment
    Methotrexate 7.5 mg per week per os escalating to 15 mg per week
    Other Names:
    • Methotrexate
    • Observation
Study Arms
  • Experimental: Methotrexate
    Chronic CSC will be given an immediate MTX treatment
    Intervention: Drug: Methotrexate
  • Experimental: Delayed treatment
    Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered
    Intervention: Drug: Delayed treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 5, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date July 2015
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Central Serous Chorioretinopathy

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Kidney disease
  • Steroid use
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633983
Other Study ID Numbers  ICMJE khateb-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edward Averbukh, Hadassah Medical Organization
Study Sponsor  ICMJE Edward Averbukh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Averbukh, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP