Toxic MaculopathyNCT02550964
Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy
An observational study of Toxic Maculopathy, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Toxic Maculopathy
- What is being tested?
- Composite Examination
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Jan 2019
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The purpose of this cohort study is to evaluate the incidence and risk factor. We will recruit a total of 124 participants considering the study budget.
Who may be able to join
- Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
- Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy
Who cannot join
- Aged less than 19 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
JooYong Lee, Professor, +82-2-3010-3976, ophthalmo@amc.seoul.kr
About this study
Official title: Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine
The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.
- Conditions
- Toxic Maculopathy
- Being tested
- Composite Examination
- Keywords
- Autoimmune Disease, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Hydroxychloroquine(HCQ), Chloroquine(CQ), Toxic Maculopathy
- Medical subject headings
- Autoimmune Diseases, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite ExaminationProcedure or surgery
First, patients will get the baseline ophthalmologic exam and medical evaluation by physicians. As a diagnostic method, the composite examination including fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography will be tested once every year.
| Study group | Role | What they receive |
|---|---|---|
| HCQ/CQ | Patients who treated with HCQ(Hydroxychloroquine) or CQ(Chloroquine) for autoimmune diseases such as Rheumatoid arthritis(RA), systemic lupus erythematosus(SLE) will be recruited, and get the composite examination for toxic maculopathy. Receives: Procedure: Composite Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxic maculopathy associated with HCQ or CQ
Measured: 1 years
Secondary outcomes (3)
Risk factor of HCQ/CQ retinopathy
Measured: 5 years
Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)
Measured: 5 years
Progression of retinopathy after drug cessation
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic MaculopathyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JooYong Lee, Asan Medical Center
- Investigators
- JooYong Lee, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550964
- Sponsor's protocol ID
- 2013-0826
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine
- ClinicalTrials.gov ID
- NCT02550964
- Acronym / sponsor ID
- 2013-0826
- Conditions
- Toxic Maculopathy
- Keywords
- Autoimmune Disease, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Hydroxychloroquine(HCQ), Chloroquine(CQ), Toxic Maculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 16 Sep 2015 (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 evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCQ/CQ | – | Procedure: Composite ExaminationPatients who treated with HCQ(Hydroxychloroquine) or CQ(Chloroquine) for autoimmune diseases such as Rheumatoid arthritis(RA), systemic lupus erythematosus(SLE) will be recruited, and get the composite examination for toxic maculopathy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The purpose of this cohort study is to evaluate the incidence and risk factor. We will recruit a total of 124 participants considering the study budget.
Key inclusion criteria (2 listed)
- Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
- Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy
Key exclusion criteria (1 listed)
- Aged less than 19 years
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 |
|---|---|---|
| Composite ExaminationFirst, patients will get the baseline ophthalmologic exam and medical evaluation by physicians. As a diagnostic method, the composite examination including fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography will be tested once every year. | Procedure or surgery | HCQ/CQ |
Primary outcome
Incidence of toxic maculopathy associated with HCQ or CQ
Time frame: 1 years
3 secondary outcomes
Risk factor of HCQ/CQ retinopathy
Time frame: 5 years
Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)
Time frame: 5 years
Progression of retinopathy after drug cessation
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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.
JooYong Lee, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxic Maculopathy, run by Asan Medical Center at 1 site in South Korea.
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 2 inclusion and 1 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 18 Sep 2015. 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 South Korea. 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.
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?
Contact JooYong Lee (+82-2-3010-3976, ophthalmo@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxic maculopathy associated with HCQ or CQ (time frame: 1 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 18 Sep 2015.