Status:
RECRUITING
Novel ERG for Detection of Hydroxychloroquine Retinopathy
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
LUPUS UK
King's College Hospital Charity
Conditions:
Hydroxychloroquine Retinopathy
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to investigate novel electroretinography (ERG) devices in the detection of hydroxychloroquine retinopathy. Two devices (the RETEval full-field and flicker ERG and UTAS mult...
Detailed Description
Hydroxychloroquine (HCQ) is a widely used drug used to treat disorders of inflammation in the body with up to 320,000 people estimated to be on this drug in the UK alone. Retinopathy due to HCQ is a s...
Eligibility Criteria
Inclusion
- Age ≥18 years
- HCQ groups:
- a. HCQ use \>5 years for patients without any high-risk factors, or \>1 year in patients with one or more high-risk factors for HCQ retinopathy, namely: i. Dose \>5mg/kg per day actual body weight (ABW) ii. Estimated glomerular filtration rate (eGFR) of \<60mls/min/1.73m2 iii. Concomitant tamoxifen use
- Control group:
- No prior HCQ exposure
Exclusion
- Cataract grade ≥3 of any subtype
- Recent cataract surgery within 4 weeks of recruitment
- Significant media opacity or corneal disease including, but not limited to, corneal oedema, corneal scarring, keratoconus, previous corneal transplants, severe keratoconjunctivitis sicca (requiring the use of topical serum, immunosuppressive or analogous therapy, or procedural treatment).
- Significant macular co-pathology including, but not limited to, macular degeneration, macular scarring, cystic macular oedema (for any reason), staphyloma.
- Inherited retinal and/or macular dystrophies including colour vision deficiencies
- Active or previous posterior uveitis or pan-uveitis
- Aphakia
- High refractive error \>6.00 dioptres
- Amblyopia
- Diabetes
- Retinal angiopathies including, but no limited to, retinal vein occlusion, retinal artery occlusion, ocular ischaemic syndrome, HIV retinopathy, Sickle cell disease, radiation retinopathy
- Visually significant surgical retinal disease including epiretinal membrane, macular hole, retinal detachment, retinal tear
- Previous retinal laser or intravitreal treatment
- Moderate or worse glaucoma
- Optic atrophy
- Photosensitive epilepsy
- Ungradable HCQ retinopathy screening images
- Periocular infection or rash (recruitment can be deferred until acute pathology has resolved)
- Unable or unwilling to undertake study activities
- Any active use or history of the following medications:
- Amiodarone Canthaxanthin Deferoxamine Digoxin Ethambutol Interferon-alpha Melatonin Nefazodone Sildenafil Vigabatrin Chloroquine Quinine
Key Trial Info
Start Date :
May 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06035887
Start Date
May 31 2024
End Date
May 1 2026
Last Update
August 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
King's College Hospital
London, London, United Kingdom, SE5 9RS