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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05112861
Other study ID # ONS-5010-007
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 15, 2021
Est. completion date March 2025

Study information

Verified date April 2024
Source Outlook Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 AvastinĀ® within 4 weeks preceding randomization - Previous use of BeovuĀ® - 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


Related Conditions & MeSH terms


Intervention

Biological:
bevacizumab
1.25 mg, intravitreal injection

Locations

Country Name City State
United States Clinical Site Chambersburg Pennsylvania
United States Clinical Site Hagerstown Maryland
United States Clinical Site Springfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Outlook Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS 3 months
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