OCS-05 in Patients With Optic Neuritis

Phase 2CompletedNCT04762017

Oculis36 enrolled

Overview

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

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. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Optic Neuritis

Interventions

OCS-05 +SoC (corticosteroid) IV administrationDRUG

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

Placebo + SoC (corticosteroid) IV administrationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: * Diagnosed with a unilateral optic neuritis * 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

Locations (4)

Hospices Civils de Lyon

Lyon, France

CHU - Nice

Nice, France

CIC Neurosciences - La Pitié Salpêtrière

Paris, France

Foundation Rothschild

Paris, France

Outcomes

Primary Outcomes

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

To determine the shift from normal to abnormal ECG parameters.

Time frame: From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)

Secondary Outcomes

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)

To determine the change in retinal layers thickness from baseline in the affected eye

Time frame: 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).

To determine the change in retinal layers thickness from baseline in the affected eye.

Time frame: 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)

To determine change in clinical vision parameters in the affected eye as compared to baseline.

Time frame: 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)

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

Time frame: 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)

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

Data from ClinicalTrials.gov

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