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OCS-05 in Patients With Acute Optic Neuritis (ACUITY)

Primary Purpose

Optic Neuritis, Optic; Neuritis, With Demyelination

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

OCS-05 IV administration

Placebo IV administration

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Acute Optic Neuritis (AON), Demyelination, Optic Neuritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Diagnosed with a unilateral acute optic neuritis with a demyelinating origin
Onset of visual loss symptoms in the last 10 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 MOG antibody associated disorder (MOGAD) or Multiple Sclerosis (MS) (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 oedema, 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

Sites / Locations

Hospices Civils de LyonRecruiting
CHU - NiceRecruiting
CIC Neurosciences - La Pitié SalpêtrièreRecruiting
Foundation RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OCS-05

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

To summarize the incidence of clinically notable laboratory abnormalities

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

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

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

Characterize the PK profile of OCS-05 3mg/kg

Full Information

NCT ID

NCT04762017

First Posted

February 17, 2021

Last Updated

May 9, 2023

Sponsor

Oculis

Collaborators

Neurotrials

1. Study Identification

Unique Protocol Identification Number

NCT04762017

Brief Title

OCS-05 in Patients With Acute Optic Neuritis

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oculis

Collaborators

Neurotrials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Optic Neuritis, Optic; Neuritis, With Demyelination

Keywords

Acute Optic Neuritis (AON), Demyelination, Optic Neuritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OCS-05

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

OCS-05 IV administration

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo IV administration

Intervention Description

Placebo IV administration for 5 consecutive days

Primary Outcome Measure Information:

Title

Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group)

Description

To determine if OCS-05 treatment is associated within increase of adverse event

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Description

To determine the change in retinal layers thickness as compared to baseline in the affected eye

Time Frame

up to 6 months

Title

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

Description

Change in clinical vision parameters in the affected eye as compared to baseline

Time Frame

up to 6 months

Title

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

Description

Change in electrophysiological parameters in the affected eye as compared to baseline

Time Frame

Up to 6 months

Title

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

Description

Change in neurological parameters in the affected eye as compared to baseline

Time Frame

Up to 6 months

Title

To summarize the incidence of clinically notable laboratory abnormalities

Description

Change in safety laboratory parameters as compared to baseline

Time Frame

Up to 6 months

Title

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

Description

Characterize the PK profile of OCS-05 3mg/kg

Time Frame

Day 1

Title

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

Description

Characterize the PK profile of OCS-05 3mg/kg

Time Frame

Day 1

Title

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

Description

Characterize the PK profile of OCS-05 3mg/kg

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Acuity Study Team

Phone

+1 617 928 5886

info@oculis.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanne Chang, MD

Organizational Affiliation

Oculis

Official's Role

Study Director

Facility Information:

Facility Name

Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69677

Country

France

Individual Site Status

Recruiting

Facility Name

CHU - Nice

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Name

CIC Neurosciences - La Pitié Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Name

Foundation Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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OCS-05 in Patients With Acute Optic Neuritis

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