Escherichia coli strain Nissle 1917 for Non-infectious uveitis|Autoimmune uveitis

Inclusion criteria

• {"criterion_text":"- Principal inclusion criteria: Adults ≥ 18 and < 65 years of age with autoimmune anterior, intermediate, posterior or pan-uveitis, who experienced flare-up of uveitis within 6 months prior to baseline visit"}

Exclusion criteria

• {"criterion_text":"- Principal exclusion criteria: Uveitis of infectious etiology, active uveitis requiring an increase in systemic therapy or initiation of biological treatment, etc. (See study protocol for full list)"}

Primary endpoints

• {"endpoint_text":"- Time to first disease relapse from the baseline visit (V2)","definition_or_measurement_approach":"Time measured from baseline visit (V2) to occurrence of first disease relapse."}

Secondary endpoints

• {"endpoint_text":"- Severity of first relapse according to the SUN system","definition_or_measurement_approach":"Severity assessed according to SUN (Standardization of Uveitis Nomenclature) criteria."}
• {"endpoint_text":"- Total number of relapses during the study","definition_or_measurement_approach":"Count of relapses occurring during the study period."}
• {"endpoint_text":"- Changes in BCVA","definition_or_measurement_approach":"Change from baseline in best-corrected visual acuity (BCVA)."}
• {"endpoint_text":"- Changes in OCT parameters","definition_or_measurement_approach":"Change from baseline in optical coherence tomography (OCT) parameters."}

Czechia

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

70

Number Of Sites

1

Number Of Participants

9

Primary sponsor

Full Name

Vseobecna Fakultni Nemocnice V Praze

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"","full_name":"Czech Health Research Council (AZV MZ ČR NU23-05-00133)","duties_or_roles":"Monetary support","organisation_type":""}