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.
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
- Recruiting
Military Institute of Medicine National Research Institute
Warsaw, 04-141
Anna Byszewska, MD, PhD, 0048226816575, abyszewska@wim.mil.pl
Anna Byszewska, MD, PhD
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 group | Role | What they receive |
|---|---|---|
| ANCA-associated vasculitis patients referred for ophthalmic assessment | 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 Receives: Diagnostic Test: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted24 Jun 2026
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GPAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Manifestations of Granulomatosis With Polyangiitis.
- ClinicalTrials.gov ID
- NCT07664709
- Acronym / sponsor ID
- 8/2024/KB
- Keywords
- ocular symptoms, octa, ocular manifestations, scleritis GPA, gpa ocular involvement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANCA-associated vasculitis patients referred for ophthalmic assessment | – | Diagnostic Test: Optical coherence tomography angiographyFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ANCA positive vasculitis with any systemic symptoms Patients either with early onset of the disease or under treatment
Key inclusion criteria (2 listed)
- ANCA positive vasculitis age 18- no limit patients with onset od the disease and patients already under treatment
- -
Key exclusion criteria (2 listed)
- no consent for ophthalmic examination
- inability to udergo ophthalmic examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography angiographystandardized OCTA protocol for macula 3x3 standardized OCTA protocol for optic disc 4.5x4.5 | Diagnostic test | ANCA-associated vasculitis patients referred for ophthalmic assessment |
Primary outcome
Statistical analysis of ocular structures involvement
Time frame: from 01/2024 until 12/2026
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
1 secondary outcome
Vessel structure and density measured with OCT angiography compared to control group.
Time frame: 1/2024-12/2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 37445483Byszewska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Military Institute of Medicine National Research Institute
Warsaw, Poland
1 site in 1 country: see every site and its status.
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.