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

Phase 3

Active, not recruiting

• Conditions: Age-Related Macular Degeneration; Wet Macular Degeneration; Neovascular Age-related Macular Degeneration; BRVO - Branch Retinal Vein Occlusion; Diabetic Macular Edema
• Interventions: Biological: bevacizumab

• Registration Number: NCT05112861
• Lead Sponsor: Outlook Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Study Start: 2021-11-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological: bevacizumab	bevacizumab	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Chambersburg, Pennsylvania, United States