A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

NCT05112861 — Phase 3, Active not recruiting, 120 participants, Outlook Therapeutics, Inc.

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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

Registry	NCT05112861, acronym NORSE SEVEN
Status	Active not recruiting
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Outlook Therapeutics, Inc. (Industry)
Conditions	Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema
Interventions	bevacizumab (Biological)
Dates	start 2021-11-15, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2021-11-09, last updated 2026-04-22
Locations	3 sites in United States

-Summary

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

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+Arms and interventions

Arm	Type	Interventions	Description
Biological: bevacizumab	Experimental	Biological: bevacizumab

bevacizumab (Biological), also known as ONS-5010: 1.25 mg, intravitreal injection

+Outcome measures

Primary outcomes

Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS [3 months]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion 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

Exclusion Criteria:

* Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
* Previous use of Beovu®
* Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
* History of inadequate response to previous intravitreal anti-VEGF therapy
* History of any intraocular or periocular corticosteroid injection or implant, in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
* Active intraocular inflammation in the study eye
* Current vitreous hemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic, infectious or autoimmune-associated uveitis in either eye
* Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug , not amenable to treatment

+Locations (3)

Facility	City	Country
Clinical Site	Springfield, Illinois	United States
Clinical Site	Hagerstown, Maryland	United States
Clinical Site	Chambersburg, Pennsylvania	United States