OCS-05 in Patients With Optic Neuritis

NCT ID: NCT04762017

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2024-09-16

Brief Summary

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).

Conditions

Optic Neuritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

OCS-05 +SoC (corticosteroid IV)

Once daily IV infusions of OCS-05 + SoC (corticosteroid) (n=18) for 5 consecutive days

Group Type: EXPERIMENTAL

OCS-05 +SoC (corticosteroid) IV administration

Intervention Type: DRUG

OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days

Placebo +SoC (corticosteroid IV)

Once daily IV infusions of Placebo + SoC (corticosteroid) (n=18) for 5 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo + SoC (corticosteroid) IV administration

Intervention Type: OTHER

Placebo + SoC (corticosteroid) IV administration for 5 consecutive days

Interventions

OCS-05 +SoC (corticosteroid) IV administration

OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days

Intervention Type: DRUG

Placebo + SoC (corticosteroid) IV administration

Placebo + SoC (corticosteroid) IV administration for 5 consecutive days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with a unilateral optic neuritis
• Onset of visual loss symptoms in the last 12 days before randomization

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurotrials

UNKNOWN

Sponsor Role: collaborator

Oculis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Klier, MD, MPH

Role: STUDY_DIRECTOR

Oculis

Locations

Hospices Civils de Lyon

Lyon, , France

CHU - Nice

Nice, , France

CIC Neurosciences - La Pitié Salpêtrière

Paris, , France

Foundation Rothschild

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36991169 (View on PubMed)

Other Identifiers

2020-003147-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OCS-05_P2_01

Identifier Type: -

Identifier Source: org_study_id