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A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516278
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Outlook Therapeutics, Inc.

Study Description
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Brief Summary:
The study will evaluate the safety of ophthalmic bevacizumab 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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration BRVO - Branch Retinal Vein Occlusion Diabetic Macular Edema Biological: bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Biological: bevacizumab
ONS-5010
 Biological: bevacizumab
1.25 mg, intravitreal injection
Other Name: ONS-5010


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and incidence of treatment-emergent adverse events [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516278


Locations
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United States, Arizona
Clinical Site
Tucson, Arizona, United States, 85710
United States, California
Clinical Site
Beverly Hills, California, United States, 90211
Clinical Site
Glendale, California, United States, 91203
Clinical Site
Long Beach, California, United States, 90807
Clinical Site
Palm Desert, California, United States, 92260
Clinical Site
Poway, California, United States, 92064
United States, Florida
Clinical Site
Clearwater, Florida, United States, 33761
Clinical Site
Winter Haven, Florida, United States, 33880
United States, Illinois
Clinical Site
Oak Forest, Illinois, United States, 60452
Clinical Site
Springfield, Illinois, United States, 62704
United States, Maryland
Clinical Site
Hagerstown, Maryland, United States, 21740
United States, New Mexico
Clinical Site
Albuquerque, New Mexico, United States, 87109
United States, Pennsylvania
Clinical Site
Chambersburg, Pennsylvania, United States, 17201
United States, South Dakota
Clinical Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Clinical Site
Germantown, Tennessee, United States, 38138
United States, Texas
Clinical Site
Abilene, Texas, United States, 79606
Clinical Site
Arlington, Texas, United States, 76012
Clinical Site
McAllen, Texas, United States, 78503
Clinical Site
San Antonio, Texas, United States, 78251
Clinical Site
Willow Park, Texas, United States, 76087
Sponsors and Collaborators
Outlook Therapeutics, Inc.
More Information
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Responsible Party: Outlook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04516278    
Other Study ID Numbers: ONS-5010-003
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Wet Macular Degeneration
Retinal Diseases
Retinal Degeneration
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors