OCS-05 in Patients With Optic Neuritis

NCT04762017 | Completed Phase 2 DMC

• 2 other identifiers: OCS-05_P2_012020-003147-29
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care

Conditions

Optic Neuritis

Keywords

Acute Optic Neuritis (AON); Optic Neuritis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.

  To determine the shift from normal to abnormal ECG parameters.

  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)

  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).

  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)

  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)

  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)

  Up to 6 months

Study Arms (2)

OCS-05 +SoC (corticosteroid IV)

EXPERIMENTAL

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

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

Other: Placebo + SoC (corticosteroid) IV administration

Interventions

OCS-05 +SoC (corticosteroid) IV administration DRUG

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

OCS-05 +SoC (corticosteroid IV)

Placebo + SoC (corticosteroid) IV administration OTHER

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

Placebo +SoC (corticosteroid IV)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Oculis: lead
• Neurotrials: collaborator

Study Sites (4)

Hospices Civils de Lyon

Lyon, 69677, France

Location

CHU - Nice

Nice, 06000, France

Location

CIC Neurosciences - La Pitié Salpêtrière

Paris, 75013, France

Location

Foundation Rothschild

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 36991169 DERIVED

MeSH Terms

Conditions

Optic Neuritis

Interventions

Adrenal Cortex Hormones; Organization and Administration

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Health Services Administration

Study Officials

• Sharon Klier, MD, MPH

  Oculis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 10, 2021
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)