MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial

October 28, 2021 updated by: Mohamed Salah, Minia University

Multifocal Electro Retinogram Study of Hydroxy Chloroquine Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial."

The aim of the study to assess the multifocal ERG (mfERG) changes in SLE patients treated with chloroquine in renal patients with comparison to SLE patients without kidney affection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory

disease that involves different organs and systems. The heterogeneous nature of

the disease represents a great challenge in its diagnosis and management.1 Studies

reported that the percentage of SLE patients demonstrating ocular manifestations

can reach up to 30%.2

The pathogenesis of the ocular involvement is still unclear, but immune

complex vasculopathy and inflammatory mediators might be implicated. The most

common ocular manifestation in SLE was found to be kerato-conjunctivitis

sicca(KCS) followed by retinopathy, where is the most severe manifestation was

the optic nerve involvement, which might end up with irreversible blindness while

anterior uveitis is a rare manifestation in SLE.3

Retinal involvement can vary from subclinical vascular changes to vaso-

occlusive vision-threatening retinopathy. Lupus retinopathy is secondary to IgG

complex-mediated micro-angiopathy that leads to small vessels infarcts. Currently,

there is no agreement on existing biomarkers to identify SLE patients who have

subclinical retinal involvement, or to identify whether micro-vascular changes in

the retina are attributable to SLE.4 Lupus retinopathy is usually associated with

high disease activity especially nephritis and cerebritis. 5

On the other side, hydroxychloroquine,(HCQ) a cornerstone in lupus treatment, rarely causes ocular toxicity at doses of less than 6.5 mg/kg per day. Moreover, HCQ is found to be associated with retinopathy after a prolonged time of treatment (>5 years). 6 HCQ bind to melanin pigments in the retinal pigment epithelium (RPE). This binding may serve to concentrate the agents in the cell and contribute to their long-term effects. The classic pattern of retinal toxicity of HCQ is RPE depigmentation with foveal sparing, known as bull's-eye maculopathy. Although visual acuity in these patients seems intact, patients complain from paracentral scotomas associated with reading difficulties. Besides, reduced color perception can be seen as retinopathy symptoms. That is why it is important to evaluate the eyes before starting therapy and during follow-up visits. 7 To diagnose HCQ-induced retinopathy, various methods have been recommended, including: Spectral Domain Optical Coherence Tomography (SD-OCT), automated perimetry test, multifocal electroretinogram (mfERG), But it is controversial as to which of these methods is the Gold Standard early detection of HCQ-induced retinopathy. So it's important to find a tool that can help us diagnose early. 8 mfERG is highly sensitive among the mentioned tests and because it is an objective test, it is less dependent on the patient's response and cooperation .The mfERG objectively evaluates the electroretinographic response of the macular region, and in HCQ retinopathy, this response is reduced in the paracentral region

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Minya, Egypt
        • Minia University Hospital
        • Principal Investigator:
          • Mohamed Salah, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.

Description

Inclusion Criteria:

  • 1. Age ≥18 years old. 2. Emmetropic patients with normal fundus. 3. Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination.

Exclusion Criteria:

- 1. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.

2. Patients with significant media opacity as corneal opacity, cataract. 3. Patients with ocular diseases as glaucoma, uveitis. 4. Patients with systemic diseases as diabetes mellitus, hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
50 eyes of 25 SLE patients with renal affection (Lupus nephritis).
mfERG
Diagnostic test: mfERG
mfERG was performed by RETI Scan (Roland consulting company) and software 6.16.3.10 according to the protocol of the International Society for Clinical Electrophysiology of Vision (ISCEV)
50 eyes of 25 SLE patients without renal affection
mfERG
Diagnostic test: mfERG
mfERG was performed by RETI Scan (Roland consulting company) and software 6.16.3.10 according to the protocol of the International Society for Clinical Electrophysiology of Vision (ISCEV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of mfERG parameters
Time Frame: 3 months
Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.
3 months
Analysis of values of R1 or R2 amplitude or Ring Ratio
Time Frame: 3 months
Abnormal values of R1 or R2 amplitude or Ring Ratio (R1 / R2, R1 / R3, R1 / R4, R1 / R5) in each of the patient's eyes as abnormal mfERG.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Mohamed Salah, MD, Minia University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (ACTUAL)

November 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFERG in lupus nephritis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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