Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

OBJECTIVE: The objective of this study is to investigate whether there is a correlation between genetic mutations, beginning with an analysis of ABCA4, and Plaquenil(R)-induced retinal toxicity and to describe the phenotype of Plaquenil(R)-induced retinal toxicity. STUDY POPULATION: The study will enroll 100 patients, 18 years of age or older, found to have Plaquenil(R)-induced retinal toxicity. 200 volunteers with systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or Sj(SqrRoot)(Delta)gren s syndrome and history of Plaquenil(R) use, but without evidence of retinal toxicity, will also be recruited. DESIGN: The study is an observational study with 1-2 outpatient visits to the NEI clinic or review of medical records for off-site participants. All participants will provide a blood sample for genetic analysis. OUTCOME MEASURES: Clinical examination and blood samples will be used for genetic testing and mutation identification. The primary outcome of this study is to identify genetic mutations, starting with those in ABCA4 gene, associated with retinal toxicity in participants with a history of Plaquenil(R) use. Secondary objectives include determining the utility of testing metrics in evaluating the presence of retinal toxicity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01145196
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Faith Chen
Phone (301) 402-1369
Email chenfa@nei.nih.gov
Status Recruiting
Phase
Start date August 23, 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04956237 - Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
Recruiting NCT01432847 - Cell Collection to Study Eye Diseases
Active, not recruiting NCT04130841 - Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Active, not recruiting NCT03872479 - Single Ascending Dose Study in Participants With LCA10 Phase 1/Phase 2
Active, not recruiting NCT04636307 - Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures (CHART)
Not yet recruiting NCT06451068 - Peripheral Retina Robotically Aligned OCT Study N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Completed NCT02315170 - Assessment of Novel Intraocular Injection Guide N/A
Completed NCT00069199 - Optical Coherence Tomography Comparative Study N/A
Withdrawn NCT03603990 - Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema N/A
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Withdrawn NCT02445001 - Erythrocyte Ghost Mediated Retinal Diagnosis N/A
Completed NCT01468337 - Topical Interferon Gamma-1b for Central Serous Chorioretinopathy Phase 1/Phase 2
Completed NCT01227993 - Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy Phase 1/Phase 2
Completed NCT00792259 - Topcon 3D OCT-1000 Optical Coherence Tomography System
Completed NCT00035906 - Research Study in Patients With Persistent Macular Edema Phase 2
Recruiting NCT05158699 - Effectiveness of Periocular Drug Injection in CATaract Surgery Phase 3
Terminated NCT04110015 - Assessment of Visual Function in Ophthalmic Disorders Using Virtual Visual Field Analysis
Recruiting NCT03592017 - Performance of Long-wavelength Autofluorescence Imaging N/A