mfERG in Lupus NephritisNCT05111158
MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial
An observational study of mfERG in Lupus Nephritis, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- mfERG in Lupus Nephritis
- What is being tested?
- mfERG
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minia University Hospital
Minya
Mohamed Salah, 01003321802, Mohamedzaki@mu.edu.eg
Mohamed Salah, MD
About this study
Official title: 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.
Read the 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
- Conditions
- mfERG in Lupus Nephritis
- Being tested
- mfERG
- Keywords
- mfERG, HCQ Retinopathy, Lupus nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mfERGDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| 50 eyes of 25 SLE patients with renal affection (Lupus nephritis). | mfERG Receives: Diagnostic Test: mfERG | |
| 50 eyes of 25 SLE patients without renal affection | mfERG Receives: Diagnostic Test: mfERG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of mfERG parameters
Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.
Measured: 3 months
Analysis of values of R1 or R2 amplitude or Ring Ratio
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mfERG in Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- Mohamed Salah, MD, Principal investigator, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111158
- Sponsor's protocol ID
- MFERG in lupus nephritis
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Electro Retinogram Study of Hydroxy Chloroquine Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial."
- ClinicalTrials.gov ID
- NCT05111158
- Acronym / sponsor ID
- MFERG in lupus nephritis
- Conditions
- mfERG in Lupus Nephritis
- Keywords
- mfERG, HCQ Retinopathy, Lupus nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 eyes of 25 SLE patients with renal affection (Lupus nephritis). | – | Diagnostic Test: mfERGmfERG |
| 50 eyes of 25 SLE patients without renal affection | – | Diagnostic Test: mfERGmfERG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mfERGmfERG 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) | Diagnostic test | 50 eyes of 25 SLE patients with renal affection (Lupus nephritis)., 50 eyes of 25 SLE patients without renal affection |
Primary outcome
Analysis of mfERG parameters
Time frame: 3 months
Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Salah, MD principal investigator
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of mfERG in Lupus Nephritis, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Salah, MD (01003321802, Mohamedzaki@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of mfERG parameters (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.