Visual Involvement in Giant Cell Arteritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Fluorescein and Indocyanine green Angiography: 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: 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: 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).

Study 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.

Eligibility

Primary outcome measure(s)

• Comparison of specific signs in A-AION vs. NA-AION and GCA-related CRAO vs. non-GCA-related. — Since beginning of study for 6 years
  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.

Trial sites (1)

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