Ireland
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Active, not recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Outlook Therapeutics, Inc
Phase
Phase 3
Started
2021-11-15
Last updated
2026-04-22

Condition(s) studied

Age-Related Macular DegenerationNeovascular Age-related Macular DegenerationWet Macular DegenerationBRVO - Branch Retinal Vein OcclusionDiabetic Macular Edema

Investigational drug(s) / intervention(s)

bevacizumab →

bevacizumab: 1.25 mg, intravitreal injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (3)

FacilityCityRegionStatus
Clinical Site Springfield Illinois
Clinical Site Hagerstown Maryland
Clinical Site Chambersburg Pennsylvania
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05112861 on ClinicalTrials.gov ↗ ← All trials in the USA