SLE (Systemic Lupus)NCT04866615
Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA
An observational study of SLE (Systemic Lupus), run by Minia University at 1 site in Egypt.
Trial summary
Aim of The Study To evaluate different structural retinal changes using OCT and OCT-A in patients with SLE ; newly diagnosed patients and patients on treatment and compare parameters with normal subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SLE (Systemic Lupus)
- What is being tested?
- Optvue OCT
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jun 2021to 1 Nov 2021
- 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
- Healthy volunteers accepted
- Adult
Study population: Residents of Minia Governorate diagnosed with SLE and healthy one
Who may be able to join
- Age ≥18 years old.
- Patients with SLE diagnosed by a Rheumatologist with no ocular involvement upon clinical examination
Who cannot join
- Patients with history of intraocular surgery as cataract surgery retinal detachment surgery and anti-glaucoma surgery.
- Patients with significant media opacity as corneal opacity, cataract.
- Patients with ocular diseases as glaucoma, uveitis.
- Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
- Patients with systemic diseases as diabetes mellitus (DM), hypertension, abnormal kidney functions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia university hospital
Minya
Hazem Mohamed, Resident, 01010045499, dr.hazemmohamed2013@gmail.com
About this study
Official title: Posterior Segment Evaluation of Patients With Systemic Lupus Erythematosus Using Optical Coherence Tomography and Optical Coherence Tomography Angiography
Aim of The Study To evaluate different structural retinal changes using OCT and OCT-A in patients with SLE ; newly diagnosed patients and patients on treatment and compare parameters with normal subjects
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. Studies
reported that the percentage of SLE patients demonstrating ocular manifestations
can reach up to 30%.
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.
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. Lupus retinopathy is usually associated with
high disease activity especially nephritis and cerebritis.
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).
HCQ binds 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 para-central 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.
Modern imaging techniques have provided easier and more accurate evaluation as Optical coherence tomography (OCT) is a noninvasive imaging technology, which picks up cross-sectional pictures of the retinal layers, detect thinning of retinal nerve fiber layer and macula.
Optical coherence tomography angiography (OCTA) is a relatively new technique that allows visualization of the retina capillary bed and its subtle changes.
- Conditions
- SLE (Systemic Lupus)
- Being tested
- Optvue OCT
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optvue OCTDiagnostic test
Optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| 50 patients newly diagnosed SLE with no treatment | OCT \& OCTA for newly diagnosed SLE patients Receives: Diagnostic Test: Optvue OCT | |
| 50 patients SLE on treatment by (HCQ) at doses of less than 6.5 mg/kg per day for less than 5 years | OCT \& OCTA for on treatment SLE patients Receives: Diagnostic Test: Optvue OCT | |
| 50 normal subjects as control group of similar age and gender | OCT \& OCTA for normal subjects Receives: Diagnostic Test: Optvue OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of vessel density
comparison of vessel density of superficial and deep layers of retina in 150 subjects divided into 3 groups newly diagnosed SLE patients and SLE patients on treatment and normal subjects using OCT Angiography.
Measured: 3 months
Measurement of foveal avascular zone
- comparison of foveal avascular zone between 3 groups using OCT Angiography.
Measured: 3 months
Measurement of macular thickness
comparison of macular thickness between 3 groups using OCT.
Measured: 3 months
Measurement thickness of retinal nerve fiber layer
Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
Measured: 3 months
Measurement of thickness of ganglion cell layer complex
Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.
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 posted30 Apr 2021
- Study start4 Jun 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Mohamed Mohamed, Minia University
- Investigators
- Azza Shehab, MD, Study director, Minia University HospitalMohamed Farouk, MD, Study director, Minia University HospitalMohamed Salah, MD, Study director, Minia University HospitalHazem Mohamed, Resident, Principal investigator, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866615
- Sponsor's protocol ID
- OCT&OCTA in SLE
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larosa M, Iaccarino L, Gatto M, Punzi L, Doria A. Advances in the diagnosis and classification of systemic lupus erythematosus. Expert Rev Clin Immunol. 2016 Dec;12(12):1309-1320. doi: 10.1080/1744666X.2016.1206470. Epub 2016 Jul 8.
PubMed 27362864Shoughy SS, Tabbara KF. Ocular findings in systemic lupus erythematosus. Saudi J Ophthalmol. 2016 Apr-Jun;30(2):117-21. doi: 10.1016/j.sjopt.2016.02.001. Epub 2016 Feb 16.
PubMed 27330388El-Shereef RR, Mohamed AS, Hamdy L. Ocular manifestation of systemic lupus erythematosus. Rheumatol Int. 2013 Jun;33(6):1637-42. doi: 10.1007/s00296-011-2296-x. Epub 2011 Dec 28.
PubMed 22202921Kahwage PP, Ferriani MP, Furtado JM, de Carvalho LM, Pileggi GS, Gomes FH, Terreri MT, Magalhaes CS, Pereira RM, Sacchetti SB, Marini R, Bonfa E, Silva CA, Ferriani VP. Uveitis in childhood-onset systemic lupus erythematosus patients: a multicenter survey. Clin Rheumatol. 2017 Mar;36(3):547-553. doi: 10.1007/s10067-016-3534-0. Epub 2017 Jan 9.
PubMed 28070763Sivaraj RR, Durrani OM, Denniston AK, Murray PI, Gordon C. Ocular manifestations of systemic lupus erythematosus. Rheumatology (Oxford). 2007 Dec;46(12):1757-62. doi: 10.1093/rheumatology/kem173. Epub 2007 Aug 5.
PubMed 17681981Farrell DF. Retinal toxicity to antimalarial drugs: chloroquine and hydroxychloroquine: a neurophysiologic study. Clin Ophthalmol. 2012;6:377-83. doi: 10.2147/OPTH.S27731. Epub 2012 Mar 8.
PubMed 22457587Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF; American Academy of Ophthalmology. Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). Ophthalmology. 2016 Jun;123(6):1386-94. doi: 10.1016/j.ophtha.2016.01.058. Epub 2016 Mar 16.
PubMed 26992838
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Segment Evaluation of Patients With Systemic Lupus Erythematosus Using Optical Coherence Tomography and Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04866615
- Acronym / sponsor ID
- OCT&OCTA in SLE
- Conditions
- SLE (Systemic Lupus)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 30 Apr 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.
Aim of The Study To evaluate different structural retinal changes using OCT and OCT-A in patients with SLE ; newly diagnosed patients and patients on treatment and compare parameters with normal subjects
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. Studies
reported that the percentage of SLE patients demonstrating ocular manifestations
can reach up to 30%.
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.
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. Lupus retinopathy is usually associated with
high disease activity especially nephritis and cerebritis.
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).
HCQ binds 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 para-central 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.
Modern imaging techniques have provided easier and more accurate evaluation as Optical coherence tomography (OCT) is a noninvasive imaging technology, which picks up cross-sectional pictures of the retinal layers, detect thinning of retinal nerve fiber layer and macula.
Optical coherence tomography angiography (OCTA) is a relatively new technique that allows visualization of the retina capillary bed and its subtle changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 patients newly diagnosed SLE with no treatment | – | Diagnostic Test: Optvue OCTOCT \& OCTA for newly diagnosed SLE patients |
| 50 patients SLE on treatment by (HCQ) at doses of less than 6.5 mg/kg per day for less than 5 years | – | Diagnostic Test: Optvue OCTOCT \& OCTA for on treatment SLE patients |
| 50 normal subjects as control group of similar age and gender | – | Diagnostic Test: Optvue OCTOCT \& OCTA for normal subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Minia Governorate diagnosed with SLE and healthy one
Key inclusion criteria (2 listed)
- Age ≥18 years old.
- Patients with SLE diagnosed by a Rheumatologist with no ocular involvement upon clinical examination
Key exclusion criteria (5 listed)
- Patients with history of intraocular surgery as cataract surgery retinal detachment surgery and anti-glaucoma surgery.
- Patients with significant media opacity as corneal opacity, cataract.
- Patients with ocular diseases as glaucoma, uveitis.
- Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
- Patients with systemic diseases as diabetes mellitus (DM), hypertension, abnormal kidney functions
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 |
|---|---|---|
| Optvue OCTOptical coherence tomography | Diagnostic test | 50 normal subjects as control group of similar age and gender, 50 patients SLE on treatment by (HCQ) at doses of less than 6.5 mg/kg per day for less than 5 years, 50 patients newly diagnosed SLE with no treatment |
Primary outcome
Measurement of vessel density
Time frame: 3 months
comparison of vessel density of superficial and deep layers of retina in 150 subjects divided into 3 groups newly diagnosed SLE patients and SLE patients on treatment and normal subjects using OCT Angiography.
Measurement of foveal avascular zone
Time frame: 3 months
1) comparison of foveal avascular zone between 3 groups using OCT Angiography.
Measurement of macular thickness
Time frame: 3 months
comparison of macular thickness between 3 groups using OCT.
Measurement thickness of retinal nerve fiber layer
Time frame: 3 months
Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
Measurement of thickness of ganglion cell layer complex
Time frame: 3 months
Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Background: PubMed 27362864Larosa M, Iaccarino L, Gatto M, Punzi L, Doria A. Advances in the diagnosis and classification of systemic lupus erythematosus. Expert Rev Clin Immunol. 2016 Dec;12(12):1309-1320. doi: 10.1080/1744666X.2016.1206470. Epub 2016 Jul 8.
- Background: PubMed 27330388Shoughy SS, Tabbara KF. Ocular findings in systemic lupus erythematosus. Saudi J Ophthalmol. 2016 Apr-Jun;30(2):117-21. doi: 10.1016/j.sjopt.2016.02.001. Epub 2016 Feb 16.
- Background: PubMed 22202921El-Shereef RR, Mohamed AS, Hamdy L. Ocular manifestation of systemic lupus erythematosus. Rheumatol Int. 2013 Jun;33(6):1637-42. doi: 10.1007/s00296-011-2296-x. Epub 2011 Dec 28.
- Background: PubMed 28070763Kahwage PP, Ferriani MP, Furtado JM, de Carvalho LM, Pileggi GS, Gomes FH, Terreri MT, Magalhaes CS, Pereira RM, Sacchetti SB, Marini R, Bonfa E, Silva CA, Ferriani VP. Uveitis in childhood-onset systemic lupus erythematosus patients: a multicenter survey. Clin Rheumatol. 2017 Mar;36(3):547-553. doi: 10.1007/s10067-016-3534-0. Epub 2017 Jan 9.
- Background: PubMed 17681981Sivaraj RR, Durrani OM, Denniston AK, Murray PI, Gordon C. Ocular manifestations of systemic lupus erythematosus. Rheumatology (Oxford). 2007 Dec;46(12):1757-62. doi: 10.1093/rheumatology/kem173. Epub 2007 Aug 5.
- Background: PubMed 22457587Farrell DF. Retinal toxicity to antimalarial drugs: chloroquine and hydroxychloroquine: a neurophysiologic study. Clin Ophthalmol. 2012;6:377-83. doi: 10.2147/OPTH.S27731. Epub 2012 Mar 8.
- Background: PubMed 26992838Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF; American Academy of Ophthalmology. Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). Ophthalmology. 2016 Jun;123(6):1386-94. doi: 10.1016/j.ophtha.2016.01.058. Epub 2016 Mar 16.
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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.
Azza Shehab, MD study director
Minia University Hospital
Mohamed Farouk, MD study director
Minia University Hospital
Mohamed Salah, MD study director
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 SLE (Systemic Lupus), 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 2 inclusion and 5 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 7 Jul 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 Hazem Mohamed, Resident (+201010045499, dr.hazemmohamed2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of vessel density (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866615, which also lists 7 linked publications.
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 7 Jul 2021; AzTrials last refreshed its copy on 26 Oct 2026.