A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT ID: NCT03844074
Last Updated: 2025-03-19
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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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2018-10-01
2020-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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bevacizumab
ONS-5010
bevacizumab
1.25 mg, intravitreal injection
ranibizumab
ranibizumab
0.5mg, intravitreal injection
Interventions
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bevacizumab
1.25 mg, intravitreal injection
ranibizumab
0.5mg, intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity of 20/40 to 20/320
* Study eye must:
* Have active leakage on Fluorescein Angiogram involving the fovea
* Have edema involving the fovea
* Be free of foveal scarring
* Be free of foveal atrophy
Exclusion Criteria
* Previous subfoveal focal laser photocoagulation 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 within 1 year
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous haemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA)
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious 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 or history of allergy to fluorescein or indocyanine green, not amenable to treatment
50 Years
ALL
No
Sponsors
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Outlook Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer M Kissner, PhD
Role: STUDY_DIRECTOR
Outlook Therapeutics, Inc.
Locations
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Clinical Site
Hurstville, New South Wales, Australia
Clinical Site
Liverpool, New South Wales, Australia
Clinical Site
Sydney, New South Wales, Australia
Clinical Site
Westmead, New South Wales, Australia
Clinical Site
Brisbane, Queensland, Australia
Clinical Site
Adelaide, South Australia, Australia
Clinical Site
Hobart, Tasmania, Australia
Clinical Site
Essendon, Victoria, Australia
Clinical Site
Glen Waverley, Victoria, Australia
Countries
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Other Identifiers
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ONS-5010-001
Identifier Type: -
Identifier Source: org_study_id
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