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NCT Number: NCT05112861

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Site, Springfield, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Biological

1.25 mg, intravitreal injection

Other names: ONS-5010

Primary outcomes

  1. Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Outlook Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: NORSE SEVEN

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 9, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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