OCS-05 in Patients With Acute Optic Neuritis

Optic Neuritis Clinical Trial

— ACUITY  

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762017
• Other study ID #: OCS-05_P2_01
• Secondary ID: 2020-003147-29
• Status: Recruiting
• Phase: Phase 2
• Start date: February 11, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: Oculis
• Contact: Acuity Study Team
• Phone: +1 617 928 5886
• Email: info[@]oculis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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. Fourty-two (42) eligible patients aged 18 to 60, with recent onset (visual loss symptoms) of unilateral AON (idiopathic or associated with multiple sclerosis) will be randomized to receive OCS-05 or placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 31, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Main 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 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 d) 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

Related Conditions & MeSH terms

• Demyelinating Diseases
• Neuritis
• Optic Neuritis
• Optic; Neuritis, With Demyelination

Intervention

Drug:
• OCS-05 IV administration
Multiple Dose of OCS-05 IV administration for 5 consecutive days

Other:
• Placebo IV administration
Placebo IV administration for 5 consecutive days

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon
France	CHU - Nice	Nice
France	CIC Neurosciences - La Pitié Salpêtrière	Paris
France	Foundation Rothschild	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Oculis	Neurotrials

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group)	To determine if OCS-05 treatment is associated within increase of adverse event	up to 6 months
Secondary	Describe the change in 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) by treatment group and OCS-05 pooled group	To determine the change in retinal layers thickness as compared to baseline in the affected eye	up to 6 months
Secondary	To describe the change in visual function (high to low contrast visual acuity and Humphrey visual fields) from baseline to each time point (M1, M3, M6) by treatment group and OCS-05 pooled group	Change in clinical vision parameters in the affected eye as compared to baseline	up to 6 months
Secondary	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	Up to 6 months
Secondary	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	Up to 6 months
Secondary	To summarize the incidence of clinically notable laboratory abnormalities	Change in safety laboratory parameters as compared to baseline	Up to 6 months
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1