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Methotrexate for Central Serous Chorioretinopathy Treatment Trial (MTX4CSC)

This study is not yet open for participant recruitment.
Verified July 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Edward Averbukh, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01633983
First received: July 2, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Optical Coherence Tomography indicating the level of central serous detachment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Other Name: Methotrexate
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Central Serous Chorioretinopathy

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Kidney disease
  • Steroid use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 2, 2012
Last Updated: July 18, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by 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
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 22, 2013