Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT05111158
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of mfERG parameters', 'timeFrame': '3 months', 'description': 'Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.'}, {'measure': 'Analysis of values of R1 or R2 amplitude or Ring Ratio', 'timeFrame': '3 months', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mfERG', 'HCQ Retinopathy', 'Lupus nephritis'], 'conditions': ['mfERG in Lupus Nephritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory\n\ndisease that involves different organs and systems. The heterogeneous nature of\n\nthe disease represents a great challenge in its diagnosis and management.1 Studies\n\nreported that the percentage of SLE patients demonstrating ocular manifestations\n\ncan reach up to 30%.2\n\nThe pathogenesis of the ocular involvement is still unclear, but immune\n\ncomplex vasculopathy and inflammatory mediators might be implicated. The most\n\ncommon ocular manifestation in SLE was found to be kerato-conjunctivitis\n\nsicca(KCS) followed by retinopathy, where is the most severe manifestation was\n\nthe optic nerve involvement, which might end up with irreversible blindness while\n\nanterior uveitis is a rare manifestation in SLE.3\n\nRetinal involvement can vary from subclinical vascular changes to vaso-\n\nocclusive vision-threatening retinopathy. Lupus retinopathy is secondary to IgG\n\ncomplex-mediated micro-angiopathy that leads to small vessels infarcts. Currently,\n\nthere is no agreement on existing biomarkers to identify SLE patients who have\n\nsubclinical retinal involvement, or to identify whether micro-vascular changes in\n\nthe retina are attributable to SLE.4 Lupus retinopathy is usually associated with\n\nhigh disease activity especially nephritis and cerebritis. 5\n\nOn 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n\\- 1. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.\n\n2\\. 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.'}, 'identificationModule': {'nctId': 'NCT05111158', 'briefTitle': 'MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Multifocal Electro Retinogram Study of Hydroxy Chloroquine Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial."', 'orgStudyIdInfo': {'id': 'MFERG in lupus nephritis'}}, 'armsInterventionsModule': {'armGroups': [{'label': '50 eyes of 25 SLE patients with renal affection (Lupus nephritis).', 'description': 'mfERG', 'interventionNames': ['Diagnostic Test: mfERG']}, {'label': '50 eyes of 25 SLE patients without renal affection', 'description': 'mfERG', 'interventionNames': ['Diagnostic Test: mfERG']}], 'interventions': [{'name': 'mfERG', 'type': 'DIAGNOSTIC_TEST', 'description': '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)', 'armGroupLabels': ['50 eyes of 25 SLE patients with renal affection (Lupus nephritis).', '50 eyes of 25 SLE patients without renal affection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Salah', 'role': 'CONTACT', 'email': 'Mohamedzaki@mu.edu.eg', 'phone': '01003321802'}, {'name': 'Mohamed Salah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minia University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Mohamed Salah, MD', 'role': 'CONTACT', 'email': 'Mohamedzaki@mu.edu.eg', 'phone': '01003321802'}], 'overallOfficials': [{'name': 'Mohamed Salah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mohamed Salah', 'investigatorAffiliation': 'Minia University'}}}}