NORSE SEVEN: 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

Sponsor

Outlook Therapeutics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05112861

Collaborator

(none)

120

Enrollment

Locations

Arm

12.5

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration BRVO - Branch Retinal Vein Occlusion Diabetic Macular Edema	Biological: bevacizumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biological: bevacizumab	Biological: bevacizumab 1.25 mg, intravitreal injection Other Names: ONS-5010

Arm

Intervention/Treatment

Experimental: Biological: bevacizumab

Biological: bevacizumab

1.25 mg, intravitreal injection

Other Names:

ONS-5010

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Springfield	Illinois	United States	62704
2	Clinical Site	Hagerstown	Maryland	United States	21740
3	Clinical Site	Chambersburg	Pennsylvania	United States	17201