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Search / Trial NCT06500728

Visual Involvement in Giant Cell Arteritis

Launched by ASST FATEBENEFRATELLI SACCO · Jul 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

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

ClinConnect Summary

This clinical trial is studying how Giant Cell Arteritis (GCA) affects vision in patients. GCA is a condition that causes inflammation in blood vessels and can lead to serious eye problems, including blindness. By using advanced technology and methods, researchers want to better understand the different types of vision issues that can arise from GCA compared to other causes. The goal is to improve diagnosis and predict how patients will respond to treatment.

To participate in the trial, individuals must be at least 18 years old and either have suspected or confirmed GCA with new vision problems or be part of a control group with similar vision issues that are not related to GCA. Participants will undergo thorough evaluations to help identify the specific ways GCA affects their eyesight. This study is currently recruiting participants, and it’s important for potential volunteers to discuss their eligibility with a healthcare provider, especially if they have other eye conditions or infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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.
  • Exclusion Criteria:
  • 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

About Asst Fatebenefratelli Sacco

Asst Fatebenefratelli Sacco is a prominent healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong commitment to ethical standards and patient safety, the organization collaborates with leading researchers and healthcare professionals to explore new therapies and treatment options across various medical fields. Asst Fatebenefratelli Sacco leverages its extensive expertise and state-of-the-art facilities to contribute to the global body of medical knowledge, ultimately aiming to enhance the quality of care for patients both locally and beyond.

Locations

Milan, Lombardia, Italy

Patients applied

0 patients applied

Trial Officials

Alessandro Invernizzi, Prof.

Principal Investigator

ASST Fatebenefratelli Sacco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported