Optic NeuritisPhase 2ACUITYNCT04762017
OCS-05 in Patients With Optic Neuritis
A Phase 2 study testing OCS-05 +SoC (corticosteroid) IV administration in people with Optic Neuritis, run by Oculis at 4 sites in France.
Trial summary
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- OCS-05 +SoC (corticosteroid) IV administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Feb 2021to 16 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospices Civils de Lyon
Lyon, 69677
CHU - Nice
Nice, 06000
CIC Neurosciences - La Pitié Salpêtrière
Paris, 75013
Foundation Rothschild
Paris, 75019
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care
Read the detailed description
ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).
- Conditions
- Optic Neuritis
- Being tested
- OCS-05 +SoC (corticosteroid) IV administration, Placebo + SoC (corticosteroid) IV administration
- Keywords
- Acute Optic Neuritis (AON), Optic Neuritis
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS-05 +SoC (corticosteroid) IV administrationDrug
OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days
Placebo + SoC (corticosteroid) IV administrationOther
Placebo + SoC (corticosteroid) IV administration for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| OCS-05 +SoC (corticosteroid IV) | Experimental | Once daily IV infusions of OCS-05 + SoC (corticosteroid) (n=18) for 5 consecutive days Receives: Drug: OCS-05 +SoC (corticosteroid) IV administration |
| Placebo +SoC (corticosteroid IV) | Placebo comparator | Once daily IV infusions of Placebo + SoC (corticosteroid) (n=18) for 5 consecutive days Receives: Other: Placebo + SoC (corticosteroid) IV administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.
To determine the shift from normal to abnormal ECG parameters.
Measured: From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)
Secondary outcomes (12)
Describe the Ganglion Cell and Inner Plexiform Layer (GCIPL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6)
To determine the change in retinal layers thickness from baseline in the affected eye
Measured: Up to 6 months
Describe the Retinal Nerve Fiber Layer (RNFL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6).
To determine the change in retinal layers thickness from baseline in the affected eye.
Measured: Up to 6 months
To describe the visual function on the 2.5% ETDRS Low Contrast Letter Acuity (LCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)
To determine change in clinical vision parameters in the affected eye as compared to baseline.
Measured: Up to 6 months
To describe the visual function on the 2.5% ETDRS High Contrast Letter Acuity (HCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)
Change in clinical vision parameters in the affected eye as compared to baseline
Measured: Up to 6 months
To describe the visual function on the Humphrey visual fields evaluations change from baseline (of the affected eye) to each time point (M1, M3, M6)
Change in clinical vision parameters in the affected eye as compared to baseline
Measured: Up to 6 months
To summarize the Visual Evoked Potential latency and amplitude and the change from baseline of the affected eye to each time point (M3 and M6) by treatment group and OCS-05 pooled group
Change in electrophysiological parameters in the affected eye as compared to baseline
Measured: Up to 6 months
To summarize the EDSS (Expanded Disability Status Scale) scores and the change from baseline to each time point (M1, M3 and M6) by treatment group and OCS-05 pooled group
Change in neurological parameters in the affected eye as compared to baseline
Measured: Up to 6 months
To describe the rate of treatment switch at 6 months for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
Change in rate of treatment switch for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
Measured: 6 months
To summarize the incidence of safety parameters including clinically notable laboratory abnormalities
Change in safety laboratory parameters as compared to baseline
Measured: Up to 6 months
To describe the Cmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg
Measured: Day 1
To describe the Tmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg
Measured: Day 1
To describe the AUC0-t of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Feb 2021
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurotrials
- Responsible party
- Sponsor
- Investigators
- Sharon Klier, MD, MPH, Study director, Oculis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762017
- Sponsor's protocol ID
- OCS-05_P2_01
- Other IDs
- 2020-003147-29
- Acronym
- ACUITY
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villoslada P, Masso M, Paris S, Hutchings S, Koch A. A Phase 1 randomized study on the safety and pharmacokinetics of OCS-05, a neuroprotective disease modifying treatment for Acute Optic Neuritis and Multiple Sclerosis. Sci Rep. 2023 Mar 29;13(1):5099. doi: 10.1038/s41598-023-32278-0.
PubMed 36991169
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis
- ClinicalTrials.gov ID
- NCT04762017
- Acronym / sponsor ID
- ACUITY / OCS-05_P2_01
- Conditions
- Optic Neuritis
- Keywords
- Acute Optic Neuritis (AON), Optic Neuritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- OculisIndustry (pharma, biotech, devices)
- Collaborators
- Neurotrials
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care
Detailed description
ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCS-05 +SoC (corticosteroid IV) | Experimental | Drug: OCS-05 +SoC (corticosteroid) IV administrationOnce daily IV infusions of OCS-05 + SoC (corticosteroid) (n=18) for 5 consecutive days |
| Placebo +SoC (corticosteroid IV) | Placebo comparator | Other: Placebo + SoC (corticosteroid) IV administrationOnce daily IV infusions of Placebo + SoC (corticosteroid) (n=18) for 5 consecutive days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCS-05 +SoC (corticosteroid) IV administrationOCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days | Drug | OCS-05 +SoC (corticosteroid IV) |
| Placebo + SoC (corticosteroid) IV administrationPlacebo + SoC (corticosteroid) IV administration for 5 consecutive days | Other | Placebo +SoC (corticosteroid IV) |
Primary outcome
Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.
Time frame: From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)
To determine the shift from normal to abnormal ECG parameters.
12 secondary outcomes
Describe the Ganglion Cell and Inner Plexiform Layer (GCIPL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6)
Time frame: Up to 6 months
Describe the Retinal Nerve Fiber Layer (RNFL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6).
Time frame: Up to 6 months
To describe the visual function on the 2.5% ETDRS Low Contrast Letter Acuity (LCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)
Time frame: Up to 6 months
To describe the visual function on the 2.5% ETDRS High Contrast Letter Acuity (HCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)
Time frame: Up to 6 months
To describe the visual function on the Humphrey visual fields evaluations change from baseline (of the affected eye) to each time point (M1, M3, M6)
Time frame: Up to 6 months
To summarize the Visual Evoked Potential latency and amplitude and the change from baseline of the affected eye to each time point (M3 and M6) by treatment group and OCS-05 pooled group
Time frame: Up to 6 months
To summarize the EDSS (Expanded Disability Status Scale) scores and the change from baseline to each time point (M1, M3 and M6) by treatment group and OCS-05 pooled group
Time frame: Up to 6 months
To describe the rate of treatment switch at 6 months for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
Time frame: 6 months
To summarize the incidence of safety parameters including clinically notable laboratory abnormalities
Time frame: Up to 6 months
To describe the Cmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Time frame: Day 1
To describe the Tmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Time frame: Day 1
To describe the AUC0-t of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 36991169Villoslada P, Masso M, Paris S, Hutchings S, Koch A. A Phase 1 randomized study on the safety and pharmacokinetics of OCS-05, a neuroprotective disease modifying treatment for Acute Optic Neuritis and Multiple Sclerosis. Sci Rep. 2023 Mar 29;13(1):5099. doi: 10.1038/s41598-023-32278-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Klier, MD, MPH study director
Oculis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OCS-05 +SoC (corticosteroid) IV administration in people with Optic Neuritis, run by Oculis at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters. (time frame: From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04762017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.