Methotrexate for Central Serous Chorioretinopathy Treatment Trial

Central Serous Chorioretinopathy Clinical Trial

— MTX4CSC  

Official title:

Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01633983
• Other study ID #: khateb-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 2, 2012
• Last updated: July 18, 2012
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Central Serous Chorioretinopathy

Exclusion Criteria:

• Pregnancy

• Liver disease

• Kidney disease

• Steroid use

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Methotrexate
7.5 mg per week p.o. escalating up to 15 mg per week
• Delayed treatment
Methotrexate 7.5 mg per week per os escalating to 15 mg per week

Locations

Country	Name	City	State
Israel	Hadassah Hebrew Univercity Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Edward Averbukh

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical Coherence Tomography indicating the level of central serous detachment		2 years	No