Central Serous ChorioretinopathyPhase 2MTX4CSCNCT01633983
Methotrexate for Central Serous Chorioretinopathy Treatment Trial
A Phase 2 study testing Methotrexate and Delayed treatment in people with Central Serous Chorioretinopathy, run by Edward Averbukh at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Methotrexate and Delayed treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central Serous Chorioretinopathy
Who cannot join
- Pregnancy
- Liver disease
- Kidney disease
- Steroid use
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Hebrew Univercity Medical Center
Jerusalem, Israel, 91120
Edward Averbukh, MD, +972-508946140, edwaver@gmail.com
Samer Khateb, MD, PhD, +972-542504857, samerkhateb@gmail.com
About this study
Official title: Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy
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.
Read the 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
- Being tested
- Methotrexate, Delayed treatment
- Keywords
- Central Serous Chorioretinopathy, Methotrexate
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
7.5 mg per week p.o. escalating up to 15 mg per week
Delayed treatmentDrug
Also called Methotrexate, Observation
Methotrexate 7.5 mg per week per os escalating to 15 mg per week
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Chronic CSC will be given an immediate MTX treatment Receives: Drug: Methotrexate |
| Delayed treatment | Experimental | Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered Receives: Drug: Delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical Coherence Tomography indicating the level of central serous detachment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Averbukh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Averbukh, Hadassah Medical Organization
- Investigators
- Edward Averbukh, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633983
- Sponsor's protocol ID
- khateb-HMO-CTIL
- Acronym
- MTX4CSC
- Status last verified
- Jul 2012
- First submitted
- 2 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01633983
- Acronym / sponsor ID
- MTX4CSC / khateb-HMO-CTIL
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central Serous Chorioretinopathy, Methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Edward AverbukhUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: MethotrexateChronic CSC will be given an immediate MTX treatment |
| Delayed treatment | Experimental | Drug: Delayed treatmentAcute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Central Serous Chorioretinopathy
Key exclusion criteria (4 listed)
- Pregnancy
- Liver disease
- Kidney disease
- Steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate7.5 mg per week p.o. escalating up to 15 mg per week | Drug | Methotrexate |
| Delayed treatmentAlso: Methotrexate, ObservationMethotrexate 7.5 mg per week per os escalating to 15 mg per week | Drug | Delayed treatment |
Primary outcome
Optical Coherence Tomography indicating the level of central serous detachment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Averbukh, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate and Delayed treatment in people with Central Serous Chorioretinopathy, run by Edward Averbukh at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical Coherence Tomography indicating the level of central serous detachment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.