search
Back to results

Methotrexate for Central Serous Chorioretinopathy Treatment Trial (MTX4CSC)

Primary Purpose

Central Serous Chorioretinopathy

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Methotrexate
Delayed treatment
Sponsored by
Edward Averbukh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central Serous Chorioretinopathy, Methotrexate

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Central Serous Chorioretinopathy

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Kidney disease
  • Steroid use

Sites / Locations

  • Hadassah Hebrew Univercity Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Methotrexate

Delayed treatment

Arm Description

Chronic CSC will be given an immediate MTX treatment

Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered

Outcomes

Primary Outcome Measures

Optical Coherence Tomography indicating the level of central serous detachment

Secondary Outcome Measures

Full Information

First Posted
July 2, 2012
Last Updated
July 18, 2012
Sponsor
Edward Averbukh
search

1. Study Identification

Unique Protocol Identification Number
NCT01633983
Brief Title
Methotrexate for Central Serous Chorioretinopathy Treatment Trial
Acronym
MTX4CSC
Official Title
Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Averbukh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central Serous Chorioretinopathy, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Arm Description
Chronic CSC will be given an immediate MTX treatment
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
7.5 mg per week p.o. escalating up to 15 mg per week
Intervention Type
Drug
Intervention Name(s)
Delayed treatment
Other Intervention Name(s)
Methotrexate, Observation
Intervention Description
Methotrexate 7.5 mg per week per os escalating to 15 mg per week
Primary Outcome Measure Information:
Title
Optical Coherence Tomography indicating the level of central serous detachment
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Central Serous Chorioretinopathy Exclusion Criteria: Pregnancy Liver disease Kidney disease Steroid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Averbukh, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Hebrew Univercity Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Averbukh, MD
Phone
+972-508946140
Email
edwaver@gmail.com
First Name & Middle Initial & Last Name & Degree
Samer Khateb, MD, PhD
Phone
+972-542504857
Email
samerkhateb@gmail.com
First Name & Middle Initial & Last Name & Degree
Samer Khateb, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Methotrexate for Central Serous Chorioretinopathy Treatment Trial

We'll reach out to this number within 24 hrs