A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT ID: NCT03834753
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
228 participants
INTERVENTIONAL
2019-06-25
2021-07-08
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 25-67 letters read (20/50 to 20/320 Snellen equivalent)
* Study eye must:
* Have active leakage on Fluorescein Angiogram involving the fovea
* Have edema involving the fovea
* Be free of scarring, fibrosis, or atrophy involving the central foveal zone
Exclusion Criteria
* 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) in the study eye
* 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 , 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
Tucson, Arizona, United States
Clinical Site
Arcadia, California, United States
Clinical Site
Beverly Hills, California, United States
Clinical Site
Campbell, California, United States
Clinical Site
Glendale, California, United States
Clinical Site
Laguna Hills, California, United States
Clinical Site
Long Beach, California, United States
Clinical Site
Mountain View, California, United States
Clinical Site
Oxnard, California, United States
Clinical Site
Palm Desert, California, United States
Clinical Site
Poway, California, United States
Clinical Site
Sacramento, California, United States
Clinical Site
Santa Maria, California, United States
Clinical Site
Tustin, California, United States
Clinical Site
Golden, Colorado, United States
Clinical Site
Hamden, Connecticut, United States
Clinical Site
Clearwater, Florida, United States
Clinical Site
Pinellas Park, Florida, United States
Clinical Site
Sarasota, Florida, United States
Clinical Site
Winter Haven, Florida, United States
Clinical Site
Augusta, Georgia, United States
Clinical Site
Marietta, Georgia, United States
Clinical Site
Downers Grove, Illinois, United States
Clinical Site
Lemont, Illinois, United States
Clinical Site
Springfield, Illinois, United States
Clinical Site
Indianapolis, Indiana, United States
Clinical Site
Hagerstown, Maryland, United States
Clinical Site
Edina, Minnesota, United States
Clinical Site
St Louis, Missouri, United States
Clinical Site
Bloomfield, New Jersey, United States
Clinical Site
Albuquerque, New Mexico, United States
Clinical Site
New York, New York, United States
Clinical Site
Chambersburg, Pennsylvania, United States
Clinical Site
Monroeville, Pennsylvania, United States
Clinical Site
Rapid City, South Dakota, United States
Clinical Site
Germantown, Tennessee, United States
Clinical Site
Abilene, Texas, United States
Clinical Site
Amarillo, Texas, United States
Clinical Site
Arlington, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Grapevine, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
McAllen, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
The Woodlands, Texas, United States
Clinical Site
Willow Park, Texas, United States
Clinical Site
Salt Lake City, Utah, United States
Clinical Site
Norfolk, Virginia, United States
Clinical Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ONS-5010-002
Identifier Type: -
Identifier Source: org_study_id
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