NORSE THREE
13 evidence topics · 2 sources
Objective
Summary: purpose of the trial
The company's safety results announcement described NORSE THREE as an open-label safety study conducted to ensure an adequate number of safety exposures to ONS-5010 were available for the initial BLA submission to the FDA.
Location and study date
NORSE THREE trial dates and location
| Field | Quoted record |
|---|---|
| Study Start Date | “2020-10-01” |
| Primary Completion Date | “2021-02-10” |
| Study Completion Date | “2021-02-10” |
| Overall Status | “Completed” |
| Country | “United States” |
Study design
Summary: enrollment and disease mix
The company's safety results announcement described NORSE THREE as enrolling 197 treatment-naive and previously treated subjects with wet AMD, diabetic macular edema (DME), or branch retinal vein occlusion (BRVO), to add safety exposures ahead of the initial BLA submission.
NORSE THREE study design
| Field | Quoted record |
|---|---|
| Allocation | “N/A” |
| Intervention Model | “Single Group Assignment” |
| Masking | “None (Open Label)” |
| Primary Purpose | “Treatment” |
| Phase | “Phase 3” |
| Enrollment | “197” |
Eligibility criteria
NORSE THREE eligibility criteria
Treatment
NORSE THREE treatment regimen
| Field | Quoted record |
|---|---|
| Bevacizumab (ONS-5010) dose | “1.25 mg, intravitreal injection” |
Study outcomes
Rationale for using adverse event incidence as the primary endpoint
NORSE THREE primary outcome measure
Statistical analysis description
Number of participants (Planned and analyzed)
Summary: enrollment
The company's safety results announcement described NORSE THREE as enrolling 197 treatment-naive and previously treated subjects.
Description of analysis sets
No evidence found.
Results
Participant disposition
Summary: enrollment and adverse event incidence
The company's safety results announcement reported that 20 of the 197 enrolled patients (10%) experienced an adverse event in the study eye, most commonly associated with the injection procedure rather than the drug itself.
Baseline characteristics
No evidence found.
Efficacy results
Not applicable.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Summary: adverse event incidence and comparison to prior bevacizumab safety data
Of the 197 enrolled patients, 20 (10%) experienced an adverse event in the study eye, most commonly associated with the injection procedure. The company described the safety profile as showing no unexpected trends and as consistent with prior published bevacizumab safety data, including the 2011 CATT study.
NORSE THREE absence of serious adverse events
Study limitations
Summary: open-label, single-arm design
NORSE THREE had no comparator or masking, so its adverse-event findings cannot be compared statistically with a control arm; it was designed only to add safety exposures to the overall LYTENAVA safety database ahead of the initial BLA submission.