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
NCT ID: NCT05112861
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2021-11-15
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Biological: bevacizumab
bevacizumab
1.25 mg, intravitreal injection
Interventions
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bevacizumab
1.25 mg, intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Outlook Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Springfield, Illinois, United States
Clinical Site
Hagerstown, Maryland, United States
Clinical Site
Chambersburg, Pennsylvania, United States
Countries
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Other Identifiers
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ONS-5010-007
Identifier Type: -
Identifier Source: org_study_id
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