An observational study in GPA, Vasculitis and Microscopic Polyangiitis (MPA), sponsored by Military Institute od Medicine National Research Institute. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Military Institute od Medicine National Research Institute · Observational
The current state of knowledge on ANCA-associated vasculitis (AAV) indicates that it is a group of autoimmune diseases in which small blood vessels in various organs are affected. Disease entities included in this group are granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome).
These are rare diseases, with an incidence in Europe of approximately 20-25 cases per million people per year. There is a slight predominance among men, and the risk of developing the disease increases with age.
ANCA antibodies play a role in the pathogenesis of the disease, and inflammation within small vessels leads to damage of the vessel walls, resulting either in rupture or occlusion of the vessel lumen. Consequently, vital organs such as the kidneys, lungs, heart, nervous system, upper respiratory tract, gastrointestinal tract, and eyes may be affected.
If the disease is not diagnosed, untreated, or treated improperly, it can lead to irreversible failure of these organs and even death. Despite appropriate treatment, AAV diseases tend to relapse; therefore, therapy consists of two phases: induction therapy and maintenance therapy.
Current EULAR/EDTA guidelines for induction treatment of AAV recommend the use of cyclophosphamide (CYC) or rituximab (RTX) in combination with glucocorticosteroids in cases of severe disease. If remission is achieved after induction therapy, maintenance treatment should be initiated with drugs such as azathioprine, mycophenolate mofetil, methotrexate, or rituximab, combined with a low dose of glucocorticosteroids. Maintenance therapy should last no less than two years.
The study will focus on ophthalmological evaluation of patients diagnosed with ANCA-associated vasculitis. In this disease, all structures of the eye may be involved. The most common ocular manifestations include scleritis, keratitis, proptosis, inflammation of orbital tissues, nasolacrimal duct obstruction, and orbital involvement leading to proptosis, double vision, and restricted eye movement.
Until recently, the disease was often fatal. However, advances in diagnostics and current pharmacological treatment options, combined with appropriately aggressive immunosuppressive therapy, have significantly improved survival, enhanced patients' quality of life, and reduced mortality. Early diagnosis and prompt initiation of appropriate therapy are crucial.
The current state of knowledge on ANCA-associated vasculitis (AAV) indicates that it is a group of autoimmune diseases in which small blood vessels in various organs are affected. Disease entities included in this group are granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome).
These are rare diseases, with an incidence in Europe of approximately 20-25 cases per million people per year. There is a slight predominance among men, and the risk of developing the disease increases with age.
ANCA antibodies play a role in the pathogenesis of the disease, and inflammation within small vessels leads to damage of the vessel walls, resulting either in rupture or occlusion of the vessel lumen. Consequently, vital organs such as the kidneys, lungs, heart, nervous system, upper respiratory tract, gastrointestinal tract, and eyes may be affected.
If the disease is not diagnosed, untreated, or treated improperly, it can lead to irreversible failure of these organs and even death. Despite appropriate treatment, AAV diseases tend to relapse; therefore, therapy consists of two phases: induction therapy and maintenance therapy.
Current EULAR/EDTA guidelines for induction treatment of AAV recommend the use of cyclophosphamide (CYC) or rituximab (RTX) in combination with glucocorticosteroids in cases of severe disease. If remission is achieved after induction therapy, maintenance treatment should be initiated with drugs such as azathioprine, mycophenolate mofetil, methotrexate, or rituximab, combined with a low dose of glucocorticosteroids. Maintenance therapy should last no less than two years.
The study will focus on ophthalmological evaluation of patients diagnosed with ANCA-associated vasculitis. In this disease, all structures of the eye may be involved. The most common ocular manifestations include scleritis, keratitis, proptosis, inflammation of orbital tissues, nasolacrimal duct obstruction, and orbital involvement leading to proptosis, double vision, and restricted eye movement.
Until recently, the disease was often fatal. However, advances in diagnostics and current pharmacological treatment options, combined with appropriately aggressive immunosuppressive therapy, have significantly improved survival, enhanced patients' quality of life, and reduced mortality. Early diagnosis and prompt initiation of appropriate therapy are crucial.
In the literature there are no available data on the prevalence in our country regarding the frequency of involvement of ocular structures in this disease, and there is little information on the nature of the changes or treatment outcomes. Based on data from other populations in these rare disorders, all ocular structures can be affected. The most common ocular manifestations include scleritis, keratitis, proptosis, orbital tissue inflammation, nasolacrimal duct obstruction, orbital involvement with proptosis, diplopia, and restricted ocular motility.
For the study, patients referred for ophthalmologic consultation from the Nephrology Clinic of the Military Institute of Medicine with newly diagnosed or relapsing ANCA-positive vasculitis will be enrolled. Estimated number of patients: 60. Examinations will be performed for initial ophthalmic evaluation. If more frequent visits are required (whenever ophthalmic involvement is present), additional follow-ups will be scheduled as clinical status requires. The study is planned for a minimum duration of three years.
Ophthalmic examinations will include: visual acuity, intraocular pressure, and anterior and posterior segment examinations. Depending on the clinical situation and reported symptoms, additional tests will be performed:
OCT angiography will be performed to assess whether changes in small vessels influence the vasculature of critical structures for vision in comparison to healthy individuals.
170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.
This study's planned enrollment of 70 is below the median of 147 across 77 observational studies indexed under Vasculitis.
Browse Vasculitis studies →Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
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ANCA positive vasculitis with any systemic symptoms Patients either with early onset of the disease or under treatment
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ANCA positive vasculitis age 18- no limit patients with onset od the disease and patients already under treatment
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Exclusion Criteria:
For the study, patients referred for ophthalmologic consultation from the Nephrology Clinic of the Military Institute of Medicine National Research Institute with newly diagnosed or relapsing ANCA-positive vasculitis will be enrolled. Estimated number of patients: 60. Examinations will be performed for initial ophthalmic evaluation. If more frequent visits are required (whenever ophthalmic involvement is present), additional follow-ups will be scheduled as clinical status requires. The study is planned for a minimum duration of three years. Ophthalmic examinations will include: visual acuity, intraocular pressure, and anterior and posterior segment examinations. Depending on the clinical situation and reported symptoms, additional tests will be performed * OCT and OCT angiography * neurological assessment - pupillary light reflexes, visual field, color vision * exophthalmometry, ocular motility testing * fluorescein angiography * photographic documentation * imaging studies
Diagnostic Test: Optical coherence tomography angiography
standardized OCTA protocol for macula 3x3 standardized OCTA protocol for optic disc 4.5x4.5
Statistical analysis of ocular structures involvement
Based on data from other populations in these rare disorders, all ocular structures can be affected. The most common ocular manifestations include scleritis, keratitis, proptosis, orbital tissue inflammation, nasolacrimal duct obstruction, orbital involvement with proptosis, diplopia, and restricted ocular motility. The epidemiology data will be collected and presented in percenage data
Time frame: from 01/2024 until 12/2026
Vessel structure and density measured with OCT angiography compared to control group.
Each patient will have assessment of vessels structure and vessel density in macula and optic disc according to standardised protocols. The data will be compared to normative data in healthy controls.
Time frame: 1/2024-12/2026
Plan to share: No
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Military Institute od Medicine National Research Institute