New drug aims to shield vision during optic neuritis attacks
NCT ID NCT04762017
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tested a new drug called OCS-05 in 36 people with acute optic neuritis, a condition that inflames the optic nerve and can cause vision loss. Participants received OCS-05 or a placebo alongside standard steroid treatment for five days. The main goal was to check safety, and researchers also measured changes in retinal thickness to see if the drug might protect eye health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OCS-05 (given intravenously with corticosteroids)
- What this could lead to
- If successful, this could point toward a treatment that protects vision during optic neuritis attacks.
- What could go wrong
- This is a small, early-phase safety study with only 36 people. It is not designed to prove the drug works, and results may not lead to a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
36 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
-
Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: * Diagnosed with a unilateral optic neuritis * Onset of visual loss symptoms in the last 12 days before randomization Main Exclusion Criteria: * Optic neuropathy of non-demyelinating origin * Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs) * Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders) * Active, chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS) or Myelin Oligodendrocyte Glycoprotein Antibody associated Disorder (MOGAD)(e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency) * An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss. * Diagnosed with macular edema, severe myopia (\>6 δ) or other disease of the retina at inclusion * Known diabetic retinopathy * Known glaucoma * Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study. * Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration. * Breastfeeding or pregnant women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU - Nice
Nice, 06000, France
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CIC Neurosciences - La Pitié Salpêtrière
Paris, 75013, France
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Foundation Rothschild
Paris, 75019, France
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Hospices Civils de Lyon
Lyon, 69677, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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