A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects with Neovascular Age-related Macular Degeneration; NORSE EIGHT
1 other identifier
interventional
400
1 country
61
Brief Summary
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2024
Shorter than P25 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2024
CompletedFebruary 25, 2025
February 1, 2025
10 months
December 19, 2023
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
Study Arms (2)
ONS-5010 bevacizumab
EXPERIMENTALranibizumab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Clinical Site
Arcadia, California, 91006, United States
Clinical Site
Bakersfield, California, 93309, United States
Clinical Site
Beverly Hills, California, 90210, United States
Clinical Site
Huntington Beach, California, 92647, United States
Clinical Site
Laguna Hills, California, 92653, United States
Clinical Site
Long Beach, California, 90807, United States
Clinical Site
Modesto, California, 95356, United States
Clinical Site
Oakland, California, 94611, United States
Clinical Site
Pasadena, California, 91107, United States
Clinical Site
Poway, California, 92064, United States
Clinical Site
Sacramento, California, 95841, United States
Clinical Site
Colorado Springs, Colorado, 80909, United States
Clinical Site
Lakewood, Colorado, 80228, United States
Clinical Site
Waterford, Connecticut, 06385, United States
Clinical Site
Coral Springs, Florida, 33067, United States
Clinical Site
Fort Lauderdale, Florida, 33308, United States
Clinical Site
Jacksonville, Florida, 32216, United States
Clinical Site
Orlando, Florida, 32806, United States
Clinical Site
Stuart, Florida, 34994, United States
Clinical Site
Oak Forest, Illinois, 60452, United States
Clinical Site
Oak Park, Illinois, 03440, United States
Clinical Site
Carmel, Indiana, 46290, United States
Clinical Site
Lenexa, Kansas, 66215, United States
Clinical Site
Lexington, Kentucky, 40509, United States
Clinical Site
Hagerstown, Maryland, 21740, United States
Clinical Site
Edina, Minnesota, 55435, United States
Clinical Site
Saint Louis Park, Minnesota, 55416, United States
Clinical Site
Jackson, Mississippi, 39202, United States
Clinical Site
Teaneck, New Jersey, 07666, United States
Clinical Site
Albuquerque, New Mexico, 87109, United States
Clinical Site
Liverpool, New York, 13088, United States
Clinical Site
Oceanside, New York, 11572, United States
Clinical Site
Rochester, New York, 14620, United States
Clinical Site
Westbury, New York, 11590, United States
Clinical Site
Asheville, North Carolina, 28803, United States
Clinical Site
Hickory, North Carolina, 28602, United States
Clinical Site
Wake Forest, North Carolina, 27587, United States
Clinical Site
Winston-Salem, North Carolina, 27103, United States
Clinical Site
Edmond, Oklahoma, 73013, United States
Clinical Site
Charleston, South Carolina, 29414, United States
Clinical Site
Florence, South Carolina, 29501, United States
Clinical Site
Ladson, South Carolina, 29456, United States
Clinical Site
West Columbia, South Carolina, 29169, United States
Clinical Site
Rapid City, South Dakota, 57701, United States
Clinical Site
Germantown, Tennessee, 38138, United States
Clinical Site
Abilene, Texas, 79606, United States
Clinical Site
Arlington, Texas, 76012, United States
Clinical Site
Austin, Texas, 78705, United States
Clinical Site
Beaumont, Texas, 77707, United States
Clinical Site
Bellaire, Texas, 77401, United States
Clinical Site
Dallas, Texas, 75231, United States
Clinical Site
Round Rock, Texas, 78681, United States
Clinical Site
San Antonio, Texas, 78240, United States
Clinical Site
San Antonio, Texas, 78251, United States
Clinical Site
The Woodlands, Texas, 77384, United States
Clinical Site
Willow Park, Texas, 79606, United States
Clinical Site
Salt Lake City, Utah, 84107, United States
Clinical Site
Fairfax, Virginia, 22031, United States
Clinical Site
Lynchburg, Virginia, 24502, United States
Clinical Site
Bellevue, Washington, 98004, United States
Clinical Site
Silverdale, Washington, 98383, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2023
First Posted
January 5, 2024
Study Start
January 24, 2024
Primary Completion
November 7, 2024
Study Completion
December 5, 2024
Last Updated
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share