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Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02550964
Enrollment
124
Registered
2015-09-16
Start date
2014-01-31
Completion date
2019-01-31
Last updated
2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toxic Maculopathy

Keywords

Autoimmune Disease, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Hydroxychloroquine(HCQ), Chloroquine(CQ), Toxic Maculopathy

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.

Interventions

PROCEDUREComposite 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.

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of toxic maculopathy associated with HCQ or CQ1 years

Secondary

MeasureTime frame
Risk factor of HCQ/CQ retinopathy5 years
Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)5 years
Progression of retinopathy after drug cessation1 years

Countries

South Korea

Contacts

Primary ContactJooYong Lee
ophthalmo@amc.seoul.kr+82-2-3010-3976
Backup ContactByung-gil Moon
eye82eye@gmail.com+82-2-3010-1862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026