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New drug aims to shield vision during optic neuritis attacks

NCT ID NCT04762017

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • CIC Neurosciences - La Pitié Salpêtrière

    Paris, 75013, France

  • Foundation Rothschild

    Paris, 75019, France

  • Hospices Civils de Lyon

    Lyon, 69677, France

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