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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: Recruiting study of Retinal Disease and Genotype, sponsored by National Eye Institute (NEI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The 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 use.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2010-08-23 |
What NCT01145196 shows while recruiting
NCT01145196 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 1,224-participant average among 19 other Retinal Disease trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Retinal Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01145196 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Retinal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01145196's enrollment target sits among peer trials
320 5th of 19 higher than 15 of 19 other Retinal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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