NORSE ONE
13 evidence topics · 2 sources
Objective
NORSE ONE trial title and design
Location and study date
NORSE ONE trial dates and location
| Field | Quoted record |
|---|---|
| Study Start Date | “2018-10-01” |
| Primary Completion Date | “2020-07-23” |
| Study Completion Date | “2020-08-13” |
| Overall Status | “Completed” |
| Country | “Australia” |
Study design
NORSE ONE study design
| Field | Quoted record |
|---|---|
| Allocation | “Randomized” |
| Intervention Model | “Parallel Assignment” |
| Masking | “Double” |
| Who Masked | “Participant”, “Outcomes Assessor” |
| Primary Purpose | “Treatment” |
| Phase | “Phase 3” |
| Enrollment | “61” |
Eligibility criteria
NORSE ONE eligibility criteria
“Best corrected visual acuity of 20/40 to 20/320” (opens the source at this quote in a new tab)
“Have edema involving the fovea” (opens the source at this quote in a new tab)
“Be free of foveal scarring” (opens the source at this quote in a new tab)
“Be free of foveal atrophy” (opens the source at this quote in a new tab)
Treatment
NORSE ONE treatment regimens
| Field | Quoted record |
|---|---|
| Bevacizumab (ONS-5010) dose | “1.25 mg, intravitreal injection” |
| Ranibizumab dose | “0.5mg, intravitreal injection” |
Study outcomes
Rationale for using ETDRS best corrected visual acuity gain as the primary endpoint
NORSE ONE primary endpoint definition
NORSE ONE primary and secondary outcome measures
Statistical analysis description
Number of participants (Planned and analyzed)
Summary: participants analyzed per arm
The company's topline results announcement described the ONS-5010 arm as 25 patients and the ranibizumab arm as 23 patients within the 61-patient trial.
Description of analysis sets
No evidence found.
Results
Participant disposition
Baseline characteristics
No evidence found.
Efficacy results
Summary: proportion gaining 15 or more letters at Month 11
The company's topline results announcement reported that 2 of 25 (8%) patients on the ONS-5010 arm and 5 of 23 (22%) patients on the ranibizumab arm gained more than 15 letters of best corrected visual acuity at Month 11, favoring ranibizumab numerically in this small trial.
Summary: treatment-naive subgroup
Among treatment-naive participants, the announcement reported 2 of 6 (33%) patients on the ONS-5010 arm and 4 of 13 (31%) patients on the ranibizumab arm gaining more than 15 letters at Month 11.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Summary: safety comparable between arms
The company's topline results announcement reported no statistical differences in safety between ranibizumab and ONS-5010, and zero cases of ocular inflammation.
Study limitations
Summary: small comparator trial with results diverging from NORSE TWO
NORSE ONE was a small, 61-patient clinical experience trial in Australia, roughly 30 subjects per arm, in which a numerically smaller proportion of the ONS-5010 arm than the ranibizumab arm gained 15 or more letters, a result not repeated in the larger pivotal NORSE TWO trial.