Optic Neuritis
Conditions
Keywords
Acute Optic Neuritis (AON), Optic Neuritis
Brief summary
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis 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. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).
Interventions
DRUGOCS-05 +SoC (corticosteroid) IV administration
OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days
OTHERPlacebo + SoC (corticosteroid) IV administration
Placebo + SoC (corticosteroid) IV administration for 5 consecutive days
Sponsors
Neurotrials
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed