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

Diabetic Macular Edema Clinical Trial

— NORSE SEVEN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05112861
• Other study ID #: ONS-5010-007
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 15, 2021
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Outlook Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• BRVO - Branch Retinal Vein Occlusion
• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Retinal Diseases
• Retinal Vein Occlusion
• Vision Disorders
• Vision, Low
• Wet Macular Degeneration

Intervention

Biological:
• bevacizumab
1.25 mg, intravitreal injection

Locations

Country	Name	City	State
United States	Clinical Site	Chambersburg	Pennsylvania
United States	Clinical Site	Hagerstown	Maryland
United States	Clinical Site	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Outlook Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS		3 months