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 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: ONS-5010-007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Age-Related Macular Degeneration; Neovascular Age-related Macular Degeneration; Wet Macular Degeneration; BRVO - Branch Retinal Vein Occlusion; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (1)

Biological: bevacizumab

EXPERIMENTAL

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

1.25 mg, intravitreal injection

Also known as: ONS-5010

Biological: bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Outlook Therapeutics, Inc.: lead

Study Sites (3)

Clinical Site

Springfield, Illinois, 62704, United States

Location

Clinical Site

Hagerstown, Maryland, 21740, United States

Location

Clinical Site

Chambersburg, Pennsylvania, 17201, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Retinal Vein Occlusion

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)