NORSE SEVEN

8 evidence topics · 1 source

Objective

NORSE SEVEN trial title

“A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN” (opens the source at this quote in a new tab)

Location and study date

NORSE SEVEN trial dates and location

Field	Quoted record
Study Start Date	“2021-11-15”
Primary Completion Date	“2027-12”
Study Completion Date	“2027-12”
Overall Status	“Active, not recruiting”
Country	“United States”

Study design

NORSE SEVEN study design

Field	Quoted record
Allocation	“N/A”
Intervention Model	“Single Group Assignment”
Masking	“None (Open Label)”
Primary Purpose	“Treatment”
Phase	“Phase 3”
Enrollment	“120”

Eligibility criteria

NORSE SEVEN eligibility criteria

“Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy” (opens the source at this quote in a new tab)
“Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization” (opens the source at this quote in a new tab)
“Previous use of Beovu®” (opens the source at this quote in a new tab)
“History of inadequate response to previous intravitreal anti-VEGF therapy” (opens the source at this quote in a new tab)
“Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)” (opens the source at this quote in a new tab)

Treatment

NORSE SEVEN 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 SEVEN primary outcome measure

“Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

NORSE SEVEN planned enrollment

Field	Quoted record
Enrollment	“120”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Not applicable.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary: ongoing, single-arm bridging study

NORSE SEVEN is a single-arm, open-label study comparing ONS-5010 supplied in vials versus a pre-filled syringe, with no ranibizumab or placebo comparator; ClinicalTrials.gov lists the trial as active, not recruiting, with an estimated primary completion date of December 2027, so its results are not yet available.