Methotrexate for Central Serous Chorioretinopathy Treatment Trial

Phase 2

• Conditions: Central Serous Chorioretinopathy
• Interventions: Drug: Methotrexate; Drug: Delayed treatment

• Registration Number: NCT01633983
• Lead Sponsor: Edward Averbukh

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 Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-20
• Study Start: 2012-08
• Primary Completion: 2014-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Central Serous Chorioretinopathy

Read More

Exclusion Criteria

• Pregnancy
• Liver disease
• Kidney disease
• Steroid use

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	Chronic CSC will be given an immediate MTX treatment
Delayed treatment	Delayed treatment	Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered

Primary Outcome Measures

Name	Time	Method
Optical Coherence Tomography indicating the level of central serous detachment	2 years

Trial Locations

Locations (1)

Hadassah Hebrew Univercity Medical Center; 🇮🇱 Jerusalem, Israel