RECRUITING

Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON). The main questions it aims to answer are: * Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON? * How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo * clinical examination, including clinical history, neurovisual and neurological tests * serum and cerebrospinal fluid examination * optical coherence tomography (OCT) * magnetic resonance imaging (MRI) * assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.

Official Title

The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis

Quick Facts

Study Start:2020-08-15
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05605951

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * First-ever acute ON
  2. * Onset of visual symptoms within maximum of 30 days
  3. * Age ≥ 18 years
  4. * Ability to give written informed consent
  5. * Presence of written consent
  1. * MRI contraindication
  2. * Prior demyelinating diagnosis
  3. * Diagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic)
  4. * Pregnancy at inclusion
  5. * Relevant other diseases that conflict with study participation according to protocol
  6. * Inability to cooperate

Contacts and Locations

Study Contact

Susanna Asseyer, Dr. med.
CONTACT
030450639727
susanna.asseyer@charite.de
Hadas Stiebel-Kalish, Prof.
CONTACT
kalishhadas@gmail.com

Principal Investigator

Susanna Asseyer
PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Hadas Stiebel-Kalish
PRINCIPAL_INVESTIGATOR
Rabin Medical Center, Tel Aviv

Study Locations (Sites)

University of Colorado School of Medicine
Aurora, Colorado, 80045
United States
Harvard Medical School
Boston, Massachusetts, 02115
United States
Departments of Neurology and Ophthalmology, Mayo Clinic
Rochester, Minnesota, 55902
United States

Collaborators and Investigators

Sponsor: Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul

  • Susanna Asseyer, PRINCIPAL_INVESTIGATOR, Charite University, Berlin, Germany
  • Hadas Stiebel-Kalish, PRINCIPAL_INVESTIGATOR, Rabin Medical Center, Tel Aviv

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-15
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-08-15
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Demyelinating Diseases
  • Multiple Sclerosis
  • Neuromyelitis Optica Spectrum Disorder Attack
  • Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
  • Optic Neuritis