Methotrexate for Central Serous Chorioretinopathy Treatment Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Delayed treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Central Serous Chorioretinopathy Exclusion Criteria: Pregnancy Liver disease Kidney disease Steroid use

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br>Chronic CSC will be given an immediate MTX treatment | Drug: Methotrexate<br>* 7.5 mg per week p.o. escalating up to 15 mg per week<br>|
| Experimental: Delayed treatment<br>Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered | Drug: Delayed treatment<br>* Methotrexate 7.5 mg per week per os escalating to 15 mg per week<br>* Other names: Observation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical Coherence Tomography indicating the level of central serous detachment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Serous Chorioretinopathy, Methotrexate