A Phase 2 interventional study of OCS-05 +SoC (corticosteroid) IV administration and Placebo + SoC (corticosteroid) IV administration in Optic Neuritis, sponsored by Oculis. Completed at 4 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Oculis · Phase 2, Interventional, and Treatment
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).
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 58 interventional studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →Oculis is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily IV infusions of OCS-05 + SoC (corticosteroid) (n=18) for 5 consecutive days
Drug: OCS-05 +SoC (corticosteroid) IV administration
Once daily IV infusions of Placebo + SoC (corticosteroid) (n=18) for 5 consecutive days
Other: Placebo + SoC (corticosteroid) IV administration
OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days
Placebo + SoC (corticosteroid) IV administration for 5 consecutive days
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)
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
To describe the rate of treatment switch at 6 months for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
Change in rate of treatment switch for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis
Time frame: 6 months
To summarize the incidence of safety parameters including clinically notable laboratory abnormalities
Change in safety laboratory parameters as compared to baseline
Time frame: Up to 6 months
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Oculis