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 (NORSE SEVEN)

Outlook Therapeutics

Status and phase

Active, not recruiting

Phase 3

Conditions

Age-Related Macular Degeneration

BRVO - Branch Retinal Vein Occlusion

Diabetic Macular Edema

Wet Macular Degeneration

Neovascular Age-related Macular Degeneration

Treatments

Biological: bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05112861

ONS-5010-007

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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