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The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON).
Researchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Privosegtor | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Privosegtor | Drug | Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA). | 3 months | |
| Mean change from baseline in low contrast visual acuity (LCVA). | 3 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Development Officer | Contact | 617-928-5886 | info@oculis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kahana Oculoplastic and Orbital Surgery | Recruiting | Livonia | Michigan | 48152 | United States |
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| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D009103 | Multiple Sclerosis |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone |
| Drug |
Methylprednisolone 1 g/day IV for 5 treatment days |
|
| Placebo | Other | 0.9% sodium chloride (NaCl) solution IV for 5 treatment days |
|
| Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness. | 3 months |
| Serum neurofilament light chain (sNfL) mean change from baseline. | Through month 3 |
| Neuro-Eye Clinical Trials | Recruiting | Houston | Texas | 77074 | United States |
|
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |