Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT07113834
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of Ankylosing Spondylitis Associated Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Corrected Distance Visual Acuity (CDVA)', 'timeFrame': 'Baseline and 3-month follow-up', 'description': 'CDVA was assessed at baseline (initial presentation) and after treatment (follow-up average of 3 months), using the Logarithm of the Minimum Angle of Resolution (logMAR) scale. Improvement or deterioration in CDVA was evaluated in relation to clinical characteristics, treatment modalities, and complication development.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondylitis', 'Uveitis'], 'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': 'This study aims to understand the clinical characteristics associated with AAU in Egyptian AS patients, and the prognostic factors, in terms of the Corrected Distance Visual Acuity (CDVA).', 'detailedDescription': 'This is a one-year retrospective cohort study conducted at the Spine and Ophthalmology Clinics of Benha University - Faculty of Medicine, Egypt, between September 2023 and August 2024. The study aims to characterize the clinical features and identify prognostic factors affecting visual outcomes in patients with Ankylosing Spondylitis-associated Anterior Uveitis (ASAAU).\n\nPatients included in this study were Egyptian nationals who initially presented to the Spine Clinic with systemic symptoms of ankylosing spondylitis (AS) and were subsequently referred to the Ophthalmology Clinic due to ophthalmic complaints. Only patients who were confirmed to have both AS (diagnosed according to the Modified New York criteria and radiographic imaging) and anterior uveitis (confirmed by slit-lamp examination and supported by Optical Coherence Tomography \\[OCT\\] and Fluorescein Angiography \\[FA\\]) were enrolled.\n\nThe final sample included 26 eyes from 22 patients who fulfilled the inclusion criteria. Patients were excluded if they were non-Egyptian, had other systemic autoimmune or immunologic conditions, had uveitis due to secondary causes, had undergone ocular surgeries, did not receive uveitis treatment, were lost to follow-up, or had incomplete medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included a retrospective cohort of 22 Egyptian patients (26 eyes) diagnosed with Ankylosing Spondylitis-associated Acute Anterior Uveitis (ASAAU), who were referred to the Ophthalmology Clinics of Benha University - Faculty of Medicine from the Spine Clinic at the same institution between September 2023 and August 2024. The cohort was composed of adult patients who met the Modified New York Criteria for AS and had documented ophthalmic symptoms confirmed as AAU through clinical and imaging evaluation. All included patients had complete follow-up data and received appropriate treatment for both AS and uveitis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Egyptian nationality.\n\nAge: ≥ 18 years.\n\nConfirmed diagnosis of Ankylosing Spondylitis (AS) according to the Modified New York Criteria, including:\n\nClinical symptoms (e.g., chronic inflammatory back pain, reduced lumbar motion, reduced chest expansion)\n\nRadiographic evidence of sacroiliitis.\n\nConfirmed diagnosis of Acute Anterior Uveitis (AAU) based on:\n\nOphthalmologic examination (e.g., slit-lamp biomicroscopy)\n\nAncillary testing (e.g., Optical Coherence Tomography \\[OCT\\] and/or Fluorescein Angiography \\[FA\\]).\n\nPresentation to the Spine Clinic of Benha University - Faculty of Medicine between September 2023 and August 2024 with ophthalmic complaints, subsequently referred to the Ophthalmology Clinic.\n\nComplete medical and ophthalmologic records available.\n\nReceived treatment for both AS and AAU.\n\nAt least one follow-up visit after initiation of treatment.\n\nExclusion Criteria:\n\n* Non-Egyptian patients.\n\nHistory of other systemic autoimmune or immunological diseases (e.g., sarcoidosis, Behçet's disease, systemic lupus erythematosus).\n\nUveitis due to non-autoimmune secondary causes (e.g., infectious uveitis, trauma-related uveitis).\n\nHistory of ocular surgery prior to the episode of AAU"}, 'identificationModule': {'nctId': 'NCT07113834', 'acronym': 'uveitis', 'briefTitle': 'Characteristics of Ankylosing Spondylitis Associated Uveitis', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Characteristics of Ankylosing Spondylitis Associated Uveitis: A Retrospective Study in Egyptian Patients', 'orgStudyIdInfo': {'id': 'Ankylosing'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adalimumab', 'type': 'DRUG', 'description': 'A tumor necrosis factor-alpha (TNF-α) inhibitor used as a biologic agent for the treatment of ankylosing spondylitis. Administered subcutaneously as part of systemic immunomodulatory therapy.'}, {'name': 'Systemic corticosteroids', 'type': 'DRUG', 'description': 'Oral or intravenous corticosteroids (e.g., prednisolone) used to suppress systemic inflammation in cases of active AS or severe uveitis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13111', 'city': 'Banhā', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Benha University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ehab Mohamed Elsayed Mohamed Saad', 'investigatorAffiliation': 'Benha University'}}}}