NCT01633983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

July 2, 2012

Last Update Submit

July 18, 2012

Conditions

Central Serous Chorioretinopathy

Keywords

Central Serous ChorioretinopathyMethotrexate

Outcome Measures

Primary Outcomes (1)

  • Optical Coherence Tomography indicating the level of central serous detachment

    2 years

Study Arms (2)

Methotrexate

EXPERIMENTAL

Chronic CSC will be given an immediate MTX treatment

Drug: Methotrexate

Delayed treatment

EXPERIMENTAL

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

Drug: Delayed treatment

Interventions

MethotrexateDRUG

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

Methotrexate
Delayed treatmentDRUG

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

Also known as: Methotrexate, Observation
Delayed treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Central Serous Chorioretinopathy

You may not qualify if:

  • Pregnancy
  • Liver disease
  • Kidney disease
  • Steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew Univercity Medical Center

Jerusalem, Israel, 91120, Israel

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

MethotrexateTreatment DelayObservation

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTime-to-TreatmentPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMethodsInvestigative Techniques

Study Officials

  • Edward Averbukh, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Hadassah Mt Scopus Ophthalmology Center

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

IL(1)