Genotype - Phenotype Study of Patients With Plaquenil-induced Retinal Toxicity

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Background: \- Plaquenil (hydroxychloroquine) is an anti-inflammatory drug that is used to treat some autoimmune diseases such as lupus and rheumatoid arthritis. This drug can damage the retina by causing a condition called plaquenil-induced retinal toxicity, which may lead to vision loss. However, most people taking plaquenil do not develop this problem. Researchers are interested in studying whether differences in a person s genes explain why some people develop plaquenil-induced retinal toxicity while others do not.

Objectives: \- To investigate possible correlations between certain genes or genetic mutations and plaquenil-induced retinal toxicity.

Eligibility: * Individuals at least 18 years of age who have previously used plaquenil. * Both individuals who have and have not developed plaquenil-induced retinal toxicity will be eligible for this study.

Design: * The study requires one or two visits to the National Eye Institute or an outpatient study clinic over a maximum 2-year period. * Participants will provide a personal and family medical history, and will have a full eye examination. * Participants will also provide blood samples for testing. * No treatment will be provided as part of this protocol.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Affected participants must be 18 years of age or older and have:

‣ History of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or Sj(SqrRoot)(Delta)gren s syndrome, and

⁃ History of Plaquenil use, and

⁃ Evidence of Plaquenil -induced retinal toxicity, based on clinical findings.

• Unaffected volunteers must be 18 years of age or older and have:

‣ History of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or Sj(SqrRoot)(Delta)gren s syndrome, and

⁃ History of Plaquenil use, and

⁃ No retinal disease upon examination within the last six months.

• All participants must be able to:

‣ Provide their own consent, and

⁃ Safely provide a blood sample.

∙ \<TAB\>

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Faith F Chen
chenfa@nei.nih.gov
(301) 402-1369
Backup
Emily Y Chew, M.D.
echew@nei.nih.gov
(301) 496-6583
Time Frame
Start Date: 2010-08-23
Participants
Target number of participants: 320
Treatments
Affected
Participants affected by Plaquenil induced retinal toxicity
Unaffected
control participants without Plaquenil induced retinal toxicity
Sponsors
Leads: National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov