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Methotrexate for Central Serous Chorioretinopathy Treatment Trial (MTX4CSC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Edward Averbukh, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633983
First Posted: July 6, 2012
Last Update Posted: July 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edward Averbukh, Hadassah Medical Organization
  Purpose
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.

Condition Intervention Phase
Central Serous Chorioretinopathy Drug: Methotrexate Drug: Delayed treatment Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Edward Averbukh, Hadassah Medical Organization:

Primary Outcome Measures:
  • Optical Coherence Tomography indicating the level of central serous detachment [ Time Frame: 2 years ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate
Chronic CSC will be given an immediate MTX treatment
Drug: Methotrexate
7.5 mg per week p.o. escalating up to 15 mg per week
Experimental: Delayed treatment
Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered
Drug: Delayed treatment
Methotrexate 7.5 mg per week per os escalating to 15 mg per week
Other Names:
  • Methotrexate
  • Observation

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.
  Eligibility

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Central Serous Chorioretinopathy

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Kidney disease
  • Steroid use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633983


Locations
Israel
Hadassah Hebrew Univercity Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Edward Averbukh, MD    +972-508946140    edwaver@gmail.com   
Contact: Samer Khateb, MD, PhD    +972-542504857    samerkhateb@gmail.com   
Principal Investigator: Samer Khateb, MD, PhD         
Sponsors and Collaborators
Edward Averbukh
Investigators
Principal Investigator: Edward Averbukh, MD Hadassah Medical Organization
  More Information

Responsible Party: Edward Averbukh, Head of Hadassah Mt Scopus Ophthalmology Center, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01633983     History of Changes
Other Study ID Numbers: khateb-HMO-CTIL
First Submitted: July 2, 2012
First Posted: July 6, 2012
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by Edward Averbukh, Hadassah Medical Organization:
Central Serous Chorioretinopathy
Methotrexate

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors