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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762017
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : May 11, 2023
Sponsor:
Collaborator:
Neurotrials
Information provided by (Responsible Party):
Oculis

Study Description
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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

Condition or disease Intervention/treatment Phase
Optic Neuritis Optic; Neuritis, With Demyelination Drug: OCS-05 IV administration Other: Placebo IV administration Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OCS-05
Once daily IV infusions of OCS-05 (n=18) for 5 consecutive days
 Drug: OCS-05 IV administration
Multiple Dose of OCS-05 IV administration for 5 consecutive days
Placebo Comparator: Placebo
Once daily IV infusions of Placebo (n=18) for 5 consecutive days
 Other: Placebo IV administration
Placebo IV administration for 5 consecutive days


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group) [ Time Frame: up to 6 months ]
    To determine if OCS-05 treatment is associated within increase of adverse event


Secondary Outcome Measures :
  1. 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 [ Time Frame: up to 6 months ]
    To determine the change in retinal layers thickness as compared to baseline in the affected eye

  2. 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 [ Time Frame: up to 6 months ]
    Change in clinical vision parameters in the affected eye as compared to baseline

  3. 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 [ Time Frame: Up to 6 months ]
    Change in electrophysiological parameters in the affected eye as compared to baseline

  4. 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 [ Time Frame: Up to 6 months ]
    Change in neurological parameters in the affected eye as compared to baseline

  5. To summarize the incidence of clinically notable laboratory abnormalities [ Time Frame: Up to 6 months ]
    Change in safety laboratory parameters as compared to baseline

  6. 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 [ Time Frame: Day 1 ]
    Characterize the PK profile of OCS-05 3mg/kg

  7. 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 [ Time Frame: Day 1 ]
    Characterize the PK profile of OCS-05 3mg/kg

  8. 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 [ Time Frame: Day 1 ]
    Characterize the PK profile of OCS-05 3mg/kg


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762017


Contacts
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Contact: Acuity Study Team +1 617 928 5886 info@oculis.com

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France, 69677
CHU - Nice Recruiting
Nice, France, 06000
CIC Neurosciences - La Pitié Salpêtrière Recruiting
Paris, France, 75013
Foundation Rothschild Recruiting
Paris, France, 75019
Sponsors and Collaborators
Oculis
Neurotrials
Investigators
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Study Director: Joanne Chang, MD Oculis
More Information
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Responsible Party: Oculis
ClinicalTrials.gov Identifier: NCT04762017    
Other Study ID Numbers: OCS-05_P2_01
2020-003147-29 ( EudraCT Number )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oculis:
Acute Optic Neuritis (AON)
Demyelination
Optic Neuritis
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases