OCS-05 in Patients with Acute Optic Neuritis

Phase 2

Completed

• Conditions: Optic Neuritis; Optic; Neuritis, with Demyelination
• Interventions: Drug: OCS-05 +SoC (corticosteroid) IV administration; Other: Placebo + SoC (corticosteroid) IV administration

• Registration Number: NCT04762017
• Lead Sponsor: Oculis

Brief Summary

To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) 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. The study randomized 36 eligible patients aged between 18 to 60 with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).

Study Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Main

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.	From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)	To determine the shift from normal to abnormal ECG parameters.

Secondary Outcome Measures

Name	Time	Method
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	To determine the change in retinal layers thickness from baseline in the affected eye
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 determine the change in retinal layers thickness from baseline in the affected eye.
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 determine change in clinical vision parameters in the affected eye as compared to baseline.
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	Change in clinical vision parameters in the affected eye as compared to baseline
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	Change in clinical vision parameters in the affected eye as compared to baseline
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	Up to 6 months	Change in electrophysiological parameters in the affected eye as compared to baseline
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	Up to 6 months	Change in neurological parameters in the affected eye as compared to baseline
To describe the rate of treatment switch at 6 months for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis	6 months	Change in rate of treatment switch for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
To summarize the incidence of safety parameters including clinically notable laboratory abnormalities	Up to 6 months	Change in safety laboratory parameters as compared to baseline
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	Day 1	Characterize the PK profile of OCS-05 3mg/kg
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	Day 1	Characterize the PK profile of OCS-05 3mg/kg
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	Day 1	Characterize the PK profile of OCS-05 3mg/kg

Trial Locations

Locations (4)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU - Nice; 🇫🇷 Nice, France

CIC Neurosciences - La Pitié Salpêtrière; 🇫🇷 Paris, France

Foundation Rothschild; 🇫🇷 Paris, France