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NCT04516278 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

Official title:
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04516278
Other study ID # ONS-5010-003
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2020
Est. completion date February 10, 2021

Study information
Verified date November 2021
Source Outlook Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date February 10, 2021
Est. primary completion date February 10, 2021
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 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• bevacizumab
1.25 mg, intravitreal injection

Locations
Country Name City State
United States Clinical Site Abilene Texas
United States Clinical Site Albuquerque New Mexico
United States Clinical Site Arlington Texas
United States Clinical Site Beverly Hills California
United States Clinical Site Chambersburg Pennsylvania
United States Clinical Site Clearwater Florida
United States Clinical Site Germantown Tennessee
United States Clinical Site Glendale California
United States Clinical Site Hagerstown Maryland
United States Clinical Site Long Beach California
United States Clinical Site McAllen Texas
United States Clinical Site Oak Forest Illinois
United States Clinical Site Palm Desert California
United States Clinical Site Poway California
United States Clinical Site Rapid City South Dakota
United States Clinical Site San Antonio Texas
United States Clinical Site Springfield Illinois
United States Clinical Site Tucson Arizona
United States Clinical Site Willow Park Texas
United States Clinical Site Winter Haven Florida

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 3 months
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