Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

September 17, 2015 updated by: JooYong Lee, Asan Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of toxic maculopathy associated with HCQ or CQ
Time Frame: 1 years
1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk factor of HCQ/CQ retinopathy
Time Frame: 5 years
5 years
Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)
Time Frame: 5 years
5 years
Progression of retinopathy after drug cessation
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: JooYong Lee, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0826

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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