Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

Hydroxychloroquine Toxic Retinopathy Clinical Trial

Official title:

Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010110
• Other study ID #: TEC 2017-003
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study assesses the ocular toxicity in patients on high dose hydroxychloroquine (HCQ) as per the latest guidelines of the American Academy of Ophthalmology (AAO).

Description:

Hydroxychloroquine (HCQ) is an anti-malarial drug that is used to treat a variety of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, juvenile idiopathic arthritis and Sjogren's syndrome. Hydroxychloroquine is a less toxic metabolite of chloroquine. There is an ongoing increase in the number of patients who are using HCQ for prolonged duration because of the expanding indications and the relatively safe systemic profile.

Hydroxychloroquine can cause variable ocular adverse effects including corneal deposits, posterior sub-capsular cataract, ciliary body dysfunction and toxic retinopathy. Toxic retinopathy caused by HCQ has been recognized for many years. Patients with toxic retinopathy usually complain of blurry vision. The classical clinical picture of HCQ toxic retinopathy is a bilateral bull's-eye maculopathy, which is caused by a ring of parafoveal RPE depigmentation that spares the fovea. The exact mechanism responsible for the development of this pattern is not fully understood, however, it is believed that the primary damage is in the photoreceptors and outer nuclear layer leading to secondary disruption of the RPE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients on hydroxychloroquine therapy who came for their ophthalmology screening appointment irrespective of the duration of use of the medication.

Exclusion Criteria:

• Patients who have stopped their hydroxychloroquine medication.

Related Conditions & MeSH terms

• Hydroxychloroquine Toxic Retinopathy
• Retinal Diseases

Intervention

Diagnostic Test:
• visual field testing (10-2), spectral domain ocular coherence tomography and Fundus auto-fluorescence
The diagnosis of toxic retinopathy was based on the positivity of at least two objective tests to confirm the subjective findings. The presence or absence of toxicity was recorded.

Locations

Country	Name	City	State
Saudi Arabia	The Eye Center	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology	King Khalid University Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events as Assessed by clinical signs and ancillary tests	A data collection sheet used to collect patient's information regarding the dose per body weight and duration of hydroxychloroquineuse and any risk factors associated with the use of the medication as per the latest AAO guidelines for hydroxychloroquine screening.; Complete ophthalmic examination including assessment of visual acuity, anterior segment examination looking for corneal verticillata and a dilated fundus examination looking for retinal pigment epithelium (RPE) depigmentation either in a para-foveal or extra-macular distribution within the retina. Ancillary tests including visual field (10-2) testing, spectral domain ocular coherence tomography (SDOCT) fundus auto-fluorescence and multifocal Electroretinogram (ERG).	2 years