Chronic Central Serous ChorioretinopathyPhase 2CSC/KetoNCT00211393
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
A Phase 2 study testing ketoconazole in people with Chronic Central Serous Chorioretinopathy, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2008
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age less than 60 years
- Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).
- Be able to return for all study visits for 3 months' duration.
- Be able to provide written informed consent
- Must have sufficiently clear media to allow for adequate fundus photography
Who cannot join
- Have choroidal neovascularization.
- Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
- Have additional eye disease that compromises the visual acuity of the study eye.
- Are receiving any systemic steroid therapy
- Have any significant medical history
- Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
- Have any history of ocular conditions that may mimic CSC
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10021
About this study
Official title: A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).
Read the detailed description
A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.
Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.
On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoconazoleDrug
600mg. /day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drug: ketoconazole | Experimental | Drug: ketoconazole
Other Names:
ketoconazole
600mg. /day for 6 weeks
-------------------------------------------------------------------------------- Receives: Drug: ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (ETDRS) after 6 weeks of treatment
Measured: 18 weeks
Secondary outcomes (1)
Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Eye, Ear & Throat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LuEsther T. Mertz Retinal Research Center
- Responsible party
- Principal investigator, Joan, Manhattan Eye, Ear & Throat Hospital
- Investigators
- K. Bailey Freund, MD, Principal investigator, Manhattan Eye, Ear & Throat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211393
- Sponsor's protocol ID
- M00.013
- Acronym
- CSC/Keto
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
- ClinicalTrials.gov ID
- NCT00211393
- Acronym / sponsor ID
- CSC/Keto / M00.013
- Conditions
- Chronic Central Serous Chorioretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- LuEsther T. Mertz Retinal Research Center
- Study start
- May 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).
Detailed description
A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.
Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.
On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: ketoconazole | Experimental | Drug: ketoconazoleDrug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks -------------------------------------------------------------------------------- |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age less than 60 years
- Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).
- Be able to return for all study visits for 3 months' duration.
- Be able to provide written informed consent
- Must have sufficiently clear media to allow for adequate fundus photography
Key exclusion criteria (8 listed)
- Have choroidal neovascularization.
- Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
- Have additional eye disease that compromises the visual acuity of the study eye.
- Are receiving any systemic steroid therapy
- Have any significant medical history
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 |
|---|---|---|
| ketoconazole600mg. /day for 6 weeks | Drug | Drug: ketoconazole |
Primary outcome
Visual acuity (ETDRS) after 6 weeks of treatment
Time frame: 18 weeks
1 secondary outcome
Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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.
K. Bailey Freund, MD principal investigator
Manhattan Eye, Ear & Throat Hospital
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 ketoconazole in people with Chronic Central Serous Chorioretinopathy, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 25 Oct 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (ETDRS) after 6 weeks of treatment (time frame: 18 weeks). 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 25 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.