Ocular Manifestations of Granulomatosis With Polyangiitis.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMilitary Institute od Medicine National Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

no consent for ophthalmic examination

inability to udergo ophthalmic examination

Trial population

ANCA positive vasculitis with any systemic symptoms Patients either with early onset of the disease or under treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Optical coherence tomography angiography

    Diagnostic test

    standardized OCTA protocol for macula 3x3 standardized OCTA protocol for optic disc 4.5x4.5

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: ANCA-associated vasculitis patients referred for ophthalmic assessment1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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