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AzTrials

GPANCT07664709

Ocular Manifestations of Granulomatosis With Polyangiitis.

An observational study of GPA and Vasculitis, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GPA, Vasculitis, Microscopic Polyangiitis (MPA)
What is being tested?
Optical coherence tomography angiography
How many people
70 participants
Where
1 sitePoland
Study dates
1 Mar 2024to 31 Dec 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • ANCA positive vasculitis age 18- no limit patients with onset od the disease and patients already under treatment
  • -

Who cannot join

  • no consent for ophthalmic examination
  • inability to udergo ophthalmic examination

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site, 1 recruiting
  • Military Institute of Medicine National Research Institute

    Warsaw, 04-141

    Anna Byszewska, MD, PhD, 0048226816575, abyszewska@wim.mil.pl

    Anna Byszewska, MD, PhD

    Recruiting

Other trials in Poland

About this study

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.

Read more

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.

Read the detailed description

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:

  • anterior or posterior segment OCT
  • neurological assessment - pupillary light reflexes, visual field, color vision
  • exophthalmometry, ocular motility testing
  • fluorescein angiography
  • photographic documentation
  • imaging studies Collected data will be subjected to statistical analysis.

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.

Being tested
Optical coherence tomography angiography
Keywords
ocular symptoms, octa, ocular manifestations, scleritis GPA, gpa ocular involvement
Medical subject headings
Vasculitis, Microscopic Polyangiitis, Churg-Strauss Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical coherence tomography angiographyDiagnostic test

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

Study groups in NCT07664709
Study groupRoleWhat they receive
ANCA-associated vasculitis patients referred for ophthalmic assessmentFor 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
Receives: Diagnostic Test: Optical coherence tomography angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from 01/2024 until 12/2026

Secondary outcomes (1)
  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.

    Measured: 1/2024-12/2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start1 Mar 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
70 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07664709
Sponsor's protocol ID
8/2024/KB
Other IDs
MIMNRI 626
Status last verified
Apr 2026
First submitted
17 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Byszewska A, Skrzypiec I, Rymarz A, Niemczyk S, Rekas M. Ocular Involvement of Granulomatosis with Polyangiitis. J Clin Med. 2023 Jul 2;12(13):4448. doi: 10.3390/jcm12134448.

    PubMed 37445483

Questions about this trial

What is this clinical trial studying?

An observational study of GPA and Vasculitis, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

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 2 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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 Poland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Statistical analysis of ocular structures involvement (time frame: from 01/2024 until 12/2026). 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 NCT07664709, which also lists 1 linked publication.

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 24 Jun 2026.

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