Deep Learning in the Detection and Prediction of Hydroxychloroquine Maculopathy

NCT ID: NCT06839443

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-06-20

Brief Summary

Hydroxychloroquine retinal toxicity affects a significant number of patients using this medication. Detection of toxicity is difficult in the early stages of the disease and depends on the subjectivity of the clinician who reads the tests (optical coherence tomography, autofluorescence and visual fields). Automating the reading of these diagnostic exams could lead to earlier detection of this pathology and reduce the burden associated with interpreting these exams in the ophthalmology service. The images that are usually taken in the screening and monitoring of hydroxychloroquine toxicity by will be collected - photography of the ocular fundus and optical coherence tomography with autofluorescence.

Detailed Description

HCQ is one of the most prescribed drugs worldwide. Originally developed for the treatment and prevention of malaria, it was soon proven effective for several other non-related disorders, most commonly non-organ specific autoimmune diseases. The use of HCQ in patients with systemic lupus erythematosus (SLE), for example, is estimated at 50%, increasing to 90% in specialized centers. These numbers are likely to increase following the LUMINA study that found a survival benefit of SLE patients on HCQ. In recent years, HCQ indications have been expanding to other medical areas such as dermatological disorders and oncology. Adding to the growing list of clinical indications, there are other factors that increase HCQ prescription such as a favourable safety profile and the possibility of adjunctive use with primary therapies, leading to a growing confidence amongst physicians to start treatment.

But HCQ is not an innocuous drug. There are several HCQ related adverse effects, either from acute or chronic intake, in particular in the nervous and cardiovascular system. It is estimated that around 1.8-7.5% of patients with more than 5 years of HCQ therapy suffer from retinal toxicity, with prevalence increasing to 20% after 20 years. Other known risk factors for toxicity are a higher dose, kidney failure and concomitant tamoxifen use and it has been suggested that previous macular pathology and genetic factors should be taken in account when calculating disease probability. Due to increase in HCQ usage, HCQ maculopathy and subsequent screening has become a public health problem. Although toxicity is directly related to drug use, retinal degeneration might continue despite drug cessation, which adding to the increase of users empathises the need for early disease detection. HCQ maculopathy screening guidelines differ slightly from country to country and have been evolving over time. The American Academy of Ophthalmology recommends baseline examination with OCT, autofluorescence and visual fields with annual review after 5 years unless there are other risk factors. On the other hand, the Royal College of Ophthalmology currently suggests annual monitoring 5 years after drug therapy with OCT and Widefield FAF unless there are other risk factors.

Deep learning techniques are paving the way in image-centric specialities and promise to lower healthcare costs and increase accuracy when compared to current methods. In ophthalmology, systems are being developed for the detection of diabetic retinopathy, glaucoma and age-related macular degeneration with high sensitivity and sensibility. We believe that using RETINAI technology and a sequential analysis of HCQ toxicity patients, a higher prediction model could be achieved. Three blinded readers will validate data as controls or toxicity.

Conditions

Hidroxicloroquine Intake

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Retinopathy group

Patients with HCQ intake with retinopathy

Retinopathy group

Intervention Type: DIAGNOSTIC_TEST

OCT scans and Retinai algorithm will be performed

Control group

Patients with HCQ intake without retinopathy

Control group

Intervention Type: DIAGNOSTIC_TEST

OCT scans and Retinai algorithm will be performed

Interventions

Retinopathy group

OCT scans and Retinai algorithm will be performed

Intervention Type: DIAGNOSTIC_TEST

Control group

OCT scans and Retinai algorithm will be performed

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with > 10 years of HCQ intake

Exclusion Criteria

• Patients with ocular diseases that might mimic HCQ maculopathy or interfer with HCQ maculopathy screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Hospitalar de Lisboa Central

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Anjos, MD

Role: STUDY_CHAIR

ULS São José

Locations

Local de Saúde São José

Portugal, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Rita Anjos, MD

Role: CONTACT

RITA.Anjos@gmail.com

+351 914535963

Ana Luisa Basílio, MD

Role: CONTACT

a.luisabasilio@gmail.com

+351 96557040

Facility Contacts

Rita Anjos, MD

Role: primary

RITA.Anjos@gmail.com

+351 914535963

Ana Luisa Basílio, MD

Role: backup

a.luisabasilio@gmail.com

+351 96557040

Other Identifiers

CHULC.CI.638.2025

Identifier Type: -

Identifier Source: org_study_id