Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02550964
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : September 18, 2015
Information provided by (Responsible Party):
JooYong Lee, Asan Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment
Toxic Maculopathy Procedure: Composite Examination

Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Group/Cohort Intervention/treatment
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.
Procedure: Composite Examination
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.

Primary Outcome Measures :
  1. Incidence of toxic maculopathy associated with HCQ or CQ [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Risk factor of HCQ/CQ retinopathy [ Time Frame: 5 years ]
  2. Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy) [ Time Frame: 5 years ]
  3. Progression of retinopathy after drug cessation [ Time Frame: 1 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Aged less than 19 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02550964

Contact: JooYong Lee +82-2-3010-3976
Contact: Byung-gil Moon +82-2-3010-1862

Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: JooYong Lee, Professor    +82-2-3010-3976   
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: JooYong Lee, Professor Asan Medical Center

Responsible Party: JooYong Lee, Associate Professor, Asan Medical Center Identifier: NCT02550964     History of Changes
Other Study ID Numbers: 2013-0826
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by JooYong Lee, Asan Medical Center:
Autoimmune Disease
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Toxic Maculopathy

Additional relevant MeSH terms:
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action