Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

Toxic Maculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550964
• Other study ID #: 2013-0826
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2015
• Last updated: September 17, 2015
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: September 2015
• Source: Asan Medical Center
• Contact: JooYong Lee
• Phone: +82-2-3010-3976
• Email: ophthalmo[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Toxic Maculopathy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of toxic maculopathy associated with HCQ or CQ		1 years	Yes
Secondary	Risk factor of HCQ/CQ retinopathy		5 years	No
Secondary	Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)		5 years	No
Secondary	Progression of retinopathy after drug cessation		1 years	Yes