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

March 17, 2025 updated by: Outlook Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Clinical Site
    • California
      • 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
        • Clinical Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Clinical Site
      • Winter Haven, Florida, United States, 33880
        • Clinical Site
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • Clinical Site
      • Springfield, Illinois, United States, 62704
        • Clinical Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Clinical Site
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Clinical Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Clinical Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Clinical Site
    • Texas
      • 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
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological: bevacizumab
ONS-5010
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Names:
  • ONS-5010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and incidence of treatment-emergent adverse events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outlook Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

February 10, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONS-5010-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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