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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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