A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)

February 21, 2025 updated by: Outlook Therapeutics, Inc.

Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects with Neovascular Age-related Macular Degeneration; NORSE EIGHT

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

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
    • California
      • Arcadia, California, United States, 91006
        • Clinical Site
      • Bakersfield, California, United States, 93309
        • Clinical Site
      • Beverly Hills, California, United States, 90210
        • Clinical Site
      • Huntington Beach, California, United States, 92647
        • Clinical Site
      • Laguna Hills, California, United States, 92653
        • Clinical Site
      • Long Beach, California, United States, 90807
        • Clinical Site
      • Modesto, California, United States, 95356
        • Clinical Site
      • Oakland, California, United States, 94611
        • Clinical Site
      • Pasadena, California, United States, 91107
        • Clinical Site
      • Poway, California, United States, 92064
        • Clinical Site
      • Sacramento, California, United States, 95841
        • Clinical Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Clinical Site
      • Lakewood, Colorado, United States, 80228
        • Clinical Site
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Clinical Site
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Clinical Site
      • Fort Lauderdale, Florida, United States, 33308
        • Clinical Site
      • Jacksonville, Florida, United States, 32216
        • Clinical Site
      • Orlando, Florida, United States, 32806
        • Clinical Site
      • Stuart, Florida, United States, 34994
        • Clinical Site
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • Clinical Site
      • Oak Park, Illinois, United States, 03440
        • Clinical Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Clinical Site
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Clinical Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Clinical Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Clinical Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Clinical Site
      • Saint Louis Park, Minnesota, United States, 55416
        • Clinical Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Clinical Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Clinical Site
    • New York
      • Liverpool, New York, United States, 13088
        • Clinical Site
      • Oceanside, New York, United States, 11572
        • Clinical Site
      • Rochester, New York, United States, 14620
        • Clinical Site
      • Westbury, New York, United States, 11590
        • Clinical Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Clinical Site
      • Hickory, North Carolina, United States, 28602
        • Clinical Site
      • Wake Forest, North Carolina, United States, 27587
        • Clinical Site
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Clinical Site
      • Florence, South Carolina, United States, 29501
        • Clinical Site
      • Ladson, South Carolina, United States, 29456
        • Clinical Site
      • West Columbia, South Carolina, United States, 29169
        • 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
      • Austin, Texas, United States, 78705
        • Clinical Site
      • Beaumont, Texas, United States, 77707
        • Clinical Site
      • Bellaire, Texas, United States, 77401
        • Clinical Site
      • Dallas, Texas, United States, 75231
        • Clinical Site
      • Round Rock, Texas, United States, 78681
        • Clinical Site
      • San Antonio, Texas, United States, 78240
        • Clinical Site
      • San Antonio, Texas, United States, 78251
        • Clinical Site
      • The Woodlands, Texas, United States, 77384
        • Clinical Site
      • Willow Park, Texas, United States, 79606
        • Clinical Site
    • Utah
      • Salt Lake, Utah, United States, 84107
        • Clinical Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Clinical Site
      • Lynchburg, Virginia, United States, 24502
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Clinical Site
      • Silverdale, Washington, United States, 98383
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
  • Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 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:

  • 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 hemorrhage 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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ranibizumab
Biological: ranibizumab
0.5mg, intravitreal injection
Experimental: ONS-5010 bevacizumab
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Names:
  • ONS-5010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
Time Frame: Baseline, 8 weeks
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Baseline, 8 weeks

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)

January 24, 2024

Primary Completion (Actual)

November 7, 2024

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONS-5010-008

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

product manufactured in and exported from the U.S.

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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