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Methotrexate for Central Serous Chorioretinopathy Treatment Trial

NCT ID: NCT01633983

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Conditions

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Central Serous Chorioretinopathy

Keywords

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Central Serous Chorioretinopathy Methotrexate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Methotrexate Observation

Eligibility Criteria

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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

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Edward Averbukh

OTHER

Sponsor Role lead

Responsible Party

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Edward Averbukh

Head of Hadassah Mt Scopus Ophthalmology Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Edward Averbukh, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Hebrew Univercity Medical Center

Jerusalem, Israel, Israel

Site Status

Countries

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Israel

Facility Contacts

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Edward Averbukh, MD

Role: primary

Samer Khateb, MD, PhD

Role: backup

Other Identifiers

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khateb-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id