Methotrexate for Central Serous Chorioretinopathy Treatment Trial

NCT ID: NCT01633983

Last Updated: 2012-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Central Serous Chorioretinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methotrexate

Chronic CSC will be given an immediate MTX treatment

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

7.5 mg per week p.o. escalating up to 15 mg per week

Delayed treatment

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

Group Type: EXPERIMENTAL

Delayed treatment

Intervention Type: DRUG

Methotrexate 7.5 mg per week per os escalating to 15 mg per week

Interventions

Methotrexate

7.5 mg per week p.o. escalating up to 15 mg per week

Intervention Type: DRUG

Delayed treatment

Methotrexate 7.5 mg per week per os escalating to 15 mg per week

Intervention Type: DRUG

Other Intervention Names

Methotrexate; Observation

Eligibility Criteria

Inclusion Criteria

• Central Serous Chorioretinopathy

Exclusion Criteria

• Pregnancy
• Liver disease
• Kidney disease
• Steroid use

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward Averbukh

OTHER

Sponsor Role: lead

Responsible Party

Edward Averbukh

Head of Hadassah Mt Scopus Ophthalmology Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edward Averbukh, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Hebrew Univercity Medical Center

Jerusalem, Israel, Israel

Countries

Israel

Facility Contacts

Edward Averbukh, MD

Role: primary

edwaver@gmail.com

+972-508946140

Samer Khateb, MD, PhD

Role: backup

samerkhateb@gmail.com

+972-542504857

Other Identifiers

khateb-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id