Visual Involvement in Giant Cell Arteritis

NCT06500728 | Recruiting

• 1 other identifier: Visu-GCA Trial
• Study Type: observational
• Target: 762
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Giant Cell Arteritis; Visual Impairment; Central Retinal Artery Occlusion; Anterior Ischemic Optic Neuropathy; Paracentral Acute Middle Maculopathy; Posterior Ischemic Optic Neuropathy; Retinal Ischemia; Blindness; Visual Disorder

Keywords

Giant Cell Arteritis; Visual impairment; Optical Coherence Tomography (OCT); High resolution Optical Coherence Tomography (HR-OCT); Angio-Optical Coherence Tomography (OCT-A); Fluorescein angiography; Indocyanine green angiography

Outcome Measures

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.

  Since beginning of study for 6 years

Secondary Outcomes (4)

• Frequency of the pathological phenotypes of GCA visual involvement

  Since beginning of study for 6 years

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

  At subject's enrollment

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

  Since patient's enrollment for 6 months

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

  Since patient's enrollment for 6 months

Other Outcomes (2)

• Identification of GCA biohumoral markers correlated with specific GCA ocular phenotypes

  Since beginning of study for 6 years

• Identification of GCA biohumoral markers correlated with visual prognosis

  Since beginning of study for 6 years

Study Arms (2)

GCA patients

Patients older than 18 years with clinically suspected or confirmed giant cell arteritis, who experience newly diagnosed visual impairment with suspected or confirmed correlation with vasculitis.

Diagnostic Test: Fluorescein and Indocyanine green Angiography; Diagnostic Test: High-resolution Optical Coherence Tomography; Diagnostic Test: Angio-Optical Coherence Tomography

Non arteritis patients

Patients over 18 years of age who experience newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology.

Diagnostic Test: Fluorescein and Indocyanine green Angiography; Diagnostic Test: High-resolution Optical Coherence Tomography; Diagnostic Test: Angio-Optical Coherence Tomography

Interventions

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).

Also known as: FAG and ICGA

GCA patients; Non arteritis patients

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).

Also known as: HR-OCT

GCA patients; Non arteritis patients

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).

Also known as: OCT-A

GCA patients; Non arteritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• For GCA group:
• 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.
• For control group:
• Patients older than 18 years with the ability to express valid consent to study enrolment.
• Newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology.

You may not qualify if:

• 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)
• /hepatitis B virus (HBV) infections, involving the eyes and orbital cavities.
• 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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

ASST Fatebenefratelli-Sacco

Milan, Lombardy, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis; Vision Disorders; Retinal Artery Occlusion; Optic Neuropathy, Ischemic; Blindness

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Arterial Occlusive Diseases; Optic Nerve Diseases; Cranial Nerve Diseases

Study Officials

• Alessandro Invernizzi, Prof.

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Tombetti, Prof.

CONTACT

3289098793; tombetti.enrico@asst-fbf-sacco.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 15, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

IT (1)