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

Oculis

Status and phase: Completed; Phase 2

Conditions: Optic; Neuritis, with Demyelination; Optic Neuritis

Treatments: Drug: OCS-05 +SoC (corticosteroid) IV administration; Other: Placebo + SoC (corticosteroid) IV administration

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04762017

OCS-05_P2_01

2020-003147-29 (EudraCT Number)

Details and patient eligibility

About

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

Full 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. The study randomized 36 eligible patients aged between 18 to 60 with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

OCS-05 +SoC (corticosteroid IV)

Experimental group

Description:

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

Treatment:

Drug: OCS-05 +SoC (corticosteroid) IV administration

Placebo +SoC (corticosteroid IV)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo + SoC (corticosteroid) IV administration