Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Hydroxychloroquine Toxicity Clinical Trial

Official title:

Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316092
• Other study ID #: Ocular Plaquenil Toxicity
• Status: Completed
• Phase: N/A
• First received: October 17, 2017
• Last updated: October 19, 2017
• Start date: January 7, 2010
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2017
• Source: Dr. S.S. Michel Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this medication are very serious and causes loss of central vision. In most patients these side effects are dose related, cumulative. This means that the risk of side effects would increase in all patients with continued use of the medication. In few people use of the medication would not be recommended if they have some bilateral macular problems. This is because the side effects of this medication does cause serious degredation of the macula in both eyes.

Description:

The ocular side effects of Hydroxychloroquine has been known for long time. Due to the seriousness of these side effects all possible efforts were done to prevent them. Preventing these side effects would ideally need prior screening of all patients who are to use oral Hydroxychloroquine. If patients are not screened prior to oral Hydroxychloroquine use they should be examined as soon as possible after starting this medication. Advances in technology, specifically the advent of optical coherence tomography, made screening and monitoring for Hydroxychloroquine toxicity much more easier and reliable meantime.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 10, 2017
• Est. primary completion date: January 10, 2017
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria: all patients who need treatment with oral Hydroxychloroquine.

Exclusion Criteria: patients who are not using oral Hydroxychloroquine.

Related Conditions & MeSH terms

• Hydroxychloroquine Toxicity

Intervention

Diagnostic Test:
• optical coherence tomography
screening and monitoring all patients who are to use or have been using oral Hydroxychloroquine

Locations

Country	Name	City	State
Canada	Dr. S.S. Michel Clinic	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Dr. S.S. Michel Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optical coherence tomography (OCT) is a very reliable, accessible and documented way for monitoring all people who are to use or have been using oral Hydroxychloroquine	OCT would very much help in selecting patients who may safely use oral Hydroxychloroquine. It is also the most preferred way so far for monitoring all patients who use oral Hydroxychloroquine to prevent serious and bilateral ocular side effects	Ten years