Visual Involvement in Giant Cell Arteritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorASST Fatebenefratelli Sacco

About this trial

This observational study aims to enhance the description of the different ways Giant Cell Arteritis (GCA) affects vision. The latest technology and knowledge are used to improve how we diagnose and predict patient outcomes. GCA is the most frequent vasculitis, an inflammation of vessels, in older adults. It involves large and medium-sized arteries and causes ischemic alterations such as stroke and blindness, through damage of extracranial arteries.

The primary objective is to compare the frequency of the various ocular findings between the main alterations of arteritic and non-arteritic aetiology, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) Vs. Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION) or Central Retinal Artery Occlusion (CRAO) from GCA Vs. from other causes, through a comprehensive clinical and instrumental evaluation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years with clinically suspected or confirmed gigantocellular arteritis.

Newly found visual involvement with suspected or confirmed correlation with vasculitis.

Ability to express valid consent to study enrolment.

Patients older than 18 years with the ability to express valid consent to study enrolment.

Disqualifiers

Pre-existing ophthalmological pathologies that may modify best visual acuity and/or alter ophthalmological semeiotics.

Concomitant active viral, bacterial, fungal and parasitic infections, including active or latent tuberculosis treated for less than 4 weeks and HIV, hepatitis C virus (HCV)

Concomitant systemic inflammations not attributable to GCA (inflammatory diseases in treatment-free remission are not excluded).

Any other condition judged by the investigators to be a contraindication of eligibility

Trial population

Consecutive adult patients presenting with transient or permanent visual impairment, with or without associated vasculitic pathology, at the emergency department or ophthalmology outpatient clinic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fluorescein and Indocyanine green Angiography

    Diagnostic test

    The ophthalmologist frequently recommends fluorescein (FAG) and indocyanine green angiography (ICGA) at baseline (T0) to evaluate retinal and choroidal vascularisation. They can be repeated also after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4) or 26 ± 2 weeks (T5).

  • High-resolution Optical Coherence Tomography

    Diagnostic test

    The ophthalmologist often suggests performing HR-OCT initially (T0) to assess the width of the macula and optic nerve with potential signs of ischemic lesions in these areas. This assessment can also be repeated after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

  • Angio-Optical Coherence Tomography

    Diagnostic test

    The ophthalmologist often suggests OCT-A at the beginning (T0) to assess the retinal and choroidal vascularization. These tests can also be done after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

Treatment groups

762 Participants
are divided into 2 treatment groups
Group A: GCA patients3 interventions
Group B: Non arteritis patients3 interventions

Trial outcomes

Primary outcomes

1

Comparison of specific signs in A-AION vs. NA-AION and GCA-related CRAO vs. non-GCA-related.

The primary outcome is a comparison of the frequency of the various semeiological findings by multi-parametric evaluation (visual field, fundus oculi, OCT, OCT-A, FAG, ICGA), among the main pathological ocular alterations of arteritic and non-arteritic aetiology, such as A-AION Vs. NA-AION and CRAO from arteritis Vs. CRAO from other causes.

Time frame
Since beginning of study for 6 years

Secondary outcomes

1

Frequency of the pathological phenotypes of GCA visual involvement

A description of the prevalence of the GCA visual phenotypes, including the potential co-existence of several of them, for example, paracellular retinal ischemia as in PAMM, choroidal and papillary ischemia).

Time frame
Since beginning of study for 6 years
2

Correlating the various clinical findings with different ophthalmological methods for each GCA ocular phenotype, at baseline.

Integration of clinical findings at baseline with ophthalmological methods such as visual acuity, campimetry, FAG, ICGA, OCT, and OCT-A in various pathological visual conditions.

Time frame
At subject's enrollment
3

Correlating the various clinical findings with different ophthalmological methods for each GCA ocular phenotype, during follow-up

Integration of clinical findings during follow-up with ophthalmological methods such as visual acuity, campimetry, FAG, ICGA, OCT, and OCT-A in various pathological visual conditions.

Time frame
Since patient's enrollment for 6 months
4

Visual impairment evolution over time, analysing predictors of improved or worsened evolution.

Temporal evolution of the visual acuity and semeiological findings after therapy and correlation with prognosis.

Time frame
Since patient's enrollment for 6 months

Other outcomes

1

Identification of GCA biohumoral markers correlated with specific GCA ocular phenotypes

Time frame
Since beginning of study for 6 years
2

Identification of GCA biohumoral markers correlated with visual prognosis

Time frame
Since beginning of study for 6 years

Sponsors and contacts

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