International study on first-time acute optic neuritis
The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis
Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul · NCT05605951
This study is testing how the timing of corticosteroid treatment affects vision in people having their first episode of acute optic neuritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul (other) |
| Locations | 26 sites (Aurora, Colorado and 25 other locations) |
| Trial ID | NCT05605951 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate subjects experiencing their first episode of acute optic neuritis (ON) to understand the impact of corticosteroid treatment timing on visual outcomes. Participants will undergo a series of clinical examinations, including neurovisual tests, serum and cerebrospinal fluid analysis, optical coherence tomography (OCT), and magnetic resonance imaging (MRI). The study will categorize patients based on their specific conditions, such as multiple sclerosis (MS)-associated ON or antibody-positive ON, and assess various clinical and laboratory biomarkers. The primary focus is to evaluate visual acuity at six months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are experiencing their first-ever acute optic neuritis with symptom onset within the last 30 days.
Not a fit: Patients with prior demyelinating diagnoses or other forms of optic neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for acute optic neuritis, enhancing visual outcomes for patients.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific investigation into treatment timing and its effects on visual outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First-ever acute ON * Onset of visual symptoms within maximum of 30 days * Age ≥ 18 years * Ability to give written informed consent * Presence of written consent Exclusion Criteria: * MRI contraindication * Prior demyelinating diagnosis * Diagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic) * Pregnancy at inclusion * Relevant other diseases that conflict with study participation according to protocol * Inability to cooperate
Where this trial is running
Aurora, Colorado and 25 other locations
- University of Colorado School of Medicine — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Harvard Medical School — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Departments of Neurology and Ophthalmology, Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Hospital Aleman — Buenos Aires, Argentina (NOT_YET_RECRUITING)
- Department of Neurology, Concord Hospital, Faculty of Medicine and Health — Sydney, Australia (RECRUITING)
- University of Botswana — Gaborone, Botswana (NOT_YET_RECRUITING)
- Federal University of Minas Gerais, Belo Horizonte — Minas Gerais, Brazil (NOT_YET_RECRUITING)
- Del Rosario University — Bogotá, Colombia (NOT_YET_RECRUITING)
- Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas — Bogotá, Colombia (NOT_YET_RECRUITING)
- Pontificia Universidad Javeriana — Bogotá, Colombia (NOT_YET_RECRUITING)
- Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark — Odense, Denmark (RECRUITING)
- (MIRCEM) Lyon Civil Hospices, France — Lyon, France (NOT_YET_RECRUITING)
- Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany, Department of Neurology — Berlin, Germany (RECRUITING)
- Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich — Munich, Germany (NOT_YET_RECRUITING)
- Nitte University, Karnataka — Mangalore, India (NOT_YET_RECRUITING)
- Hadassah Hebrew University — Jerusalem, Israel (NOT_YET_RECRUITING)
- Sackler School of Medicine and Rabin Medical Center — Tel Aviv, Israel (RECRUITING)
- University of Bologna — Bologna, Italy (NOT_YET_RECRUITING)
- University of Verona — Verona, Italy (RECRUITING)
- Fukushima Medical University School of Medicine — Fukushima, Japan (NOT_YET_RECRUITING)
- National Cancer Center, Seúl University — Seúl, Korea, Republic of (NOT_YET_RECRUITING)
- University of Barcelona — Barcelona, Spain (NOT_YET_RECRUITING)
- Vall d'Hebron Barcelona Hospital Campus — Barcelona, Spain (NOT_YET_RECRUITING)
- University Hospitals of Birmingham — Birmingham, United Kingdom (NOT_YET_RECRUITING)
- Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital — Oxford, United Kingdom (NOT_YET_RECRUITING)
- University Teaching Hospital in Lusaka — Lusaka, Zambia (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Susanna Asseyer — Charite University, Berlin, Germany
- Study coordinator: Susanna Asseyer, Dr. med.
- Email: susanna.asseyer@charite.de
- Phone: 030450639727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Demyelinating Diseases, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Optic Neuritis