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NCT01145196 · ClinicalTrials.gov registry record

Genotype-Phenotype Study of Patients With Plaquenil -Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene

A clinical trial of Retinal Disease and Genotype, sponsored by National Eye Institute (NEI).

Recruiting
Registry status
320
Enrollment target
1
Study location

NCT01145196 is a study of Retinal Disease and Genotype that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 320 participants, below the 1,224-participant average among 19 other Retinal Disease trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01145196, a study of Retinal Disease and Genotype, is actively recruiting participants, sponsored by National Eye Institute (NEI).

RECRUITING
Registry status
320 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2010-08-23

Sponsor

National Eye Institute (NEI)

221 total trials

What the Registry Record Tells You About NCT01145196

The ClinicalTrials.gov registry entry for NCT01145196 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,224-participant average among 19 other Retinal Disease trials with a reported enrollment target (74% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Retinal Disease appearing as the primary indexed condition, and to 0 interventions.

NCT01145196 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01145196 about?

NCT01145196 is a clinical study titled "Genotype-Phenotype Study of Patients With Plaquenil -Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene". 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,...

What is the current status of trial NCT01145196?

This trial is currently recruiting. The enrollment target is 320 participants. The study started on 2010-08-23.

What conditions does trial NCT01145196 study?

This clinical trial studies the following conditions: Retinal Disease, Genotype.

Who is sponsoring clinical trial NCT01145196?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01145196 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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