Neovascular Age-related Macular DegenerationPhase 3NCT06190093
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
A Phase 3 study testing bevacizumab and ranibizumab in people with Neovascular Age-related Macular Degeneration and Age-Related Macular Degeneration, run by Outlook Therapeutics, Inc. at 61 sites in United States.
Trial summary
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration
- What is being tested?
- bevacizumab and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 61 sitesUnited States
- Study dates
- 24 Jan 2024to 5 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Clinical Site
Abilene, Texas, 79606
Clinical Site
Albuquerque, New Mexico, 87109
Clinical Site
Arcadia, California, 91006
Clinical Site
Arlington, Texas, 76012
Clinical Site
Asheville, North Carolina, 28803
Clinical Site
Austin, Texas, 78705
Clinical Site
Bakersfield, California, 93309
Clinical Site
Beaumont, Texas, 77707
Clinical Site
Bellaire, Texas, 77401
Clinical Site
Bellevue, Washington, 98004
Clinical Site
Beverly Hills, California, 90210
Clinical Site
Carmel, Indiana, 46290
Clinical Site
Charleston, South Carolina, 29414
Clinical Site
Colorado Springs, Colorado, 80909
Clinical Site
Coral Springs, Florida, 33067
Clinical Site
Dallas, Texas, 75231
Clinical Site
Edina, Minnesota, 55435
Clinical Site
Edmond, Oklahoma, 73013
Clinical Site
Fairfax, Virginia, 22031
Clinical Site
Florence, South Carolina, 29501
Clinical Site
Fort Lauderdale, Florida, 33308
Clinical Site
Germantown, Tennessee, 38138
Clinical Site
Hagerstown, Maryland, 21740
Clinical Site
Hickory, North Carolina, 28602
Clinical Site
Huntington Beach, California, 92647
Clinical Site
Jackson, Mississippi, 39202
Clinical Site
Jacksonville, Florida, 32216
Clinical Site
Ladson, South Carolina, 29456
Clinical Site
Laguna Hills, California, 92653
Clinical Site
Lakewood, Colorado, 80228
Clinical Site
Lenexa, Kansas, 66215
Clinical Site
Lexington, Kentucky, 40509
Clinical Site
Liverpool, New York, 13088
Clinical Site
Long Beach, California, 90807
Clinical Site
Lynchburg, Virginia, 24502
Clinical Site
Modesto, California, 95356
Clinical Site
Oak Forest, Illinois, 60452
Clinical Site
Oak Park, Illinois, 03440
Clinical Site
Oakland, California, 94611
Clinical Site
Oceanside, New York, 11572
Clinical Site
Orlando, Florida, 32806
Clinical Site
Pasadena, California, 91107
Clinical Site
Poway, California, 92064
Clinical Site
Rapid City, South Dakota, 57701
Clinical Site
Rochester, New York, 14620
Clinical Site
Round Rock, Texas, 78681
Clinical Site
Sacramento, California, 95841
Clinical Site
Saint Louis Park, Minnesota, 55416
Clinical Site
Salt Lake City, Utah, 84107
Clinical Site
San Antonio, Texas, 78240
Clinical Site
San Antonio, Texas, 78251
Clinical Site
Silverdale, Washington, 98383
Clinical Site
Stuart, Florida, 34994
Clinical Site
Teaneck, New Jersey, 07666
Clinical Site
The Woodlands, Texas, 77384
Clinical Site
Wake Forest, North Carolina, 27587
Clinical Site
Waterford, Connecticut, 06385
Clinical Site
West Columbia, South Carolina, 29169
Clinical Site
Westbury, New York, 11590
Clinical Site
Willow Park, Texas, 79606
Clinical Site
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Neovascular Age-related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration
- Being tested
- bevacizumab, ranibizumab
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called ONS-5010
1.25 mg, intravitreal injection
ranibizumabBiological
0.5mg, intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| ONS-5010 bevacizumab | Experimental | Not described Receives: Biological: bevacizumab |
| ranibizumab | Active comparator | Not described Receives: Biological: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start24 Jan 2024
- Primary completion7 Nov 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outlook Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190093
- Sponsor's protocol ID
- ONS-5010-008
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2023
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT
- ClinicalTrials.gov ID
- NCT06190093
- Acronym / sponsor ID
- ONS-5010-008
- Conditions
- Neovascular Age-related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Outlook Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS-5010 bevacizumab | Experimental | Biological: bevacizumab |
| ranibizumab | Active comparator | Biological: ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabAlso: ONS-50101.25 mg, intravitreal injection | Biological | ONS-5010 bevacizumab |
| ranibizumab0.5mg, intravitreal injection | Biological | ranibizumab |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
RecruitingPhase 2
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and ranibizumab in people with Neovascular Age-related Macular Degeneration and Age-Related Macular Degeneration, run by Outlook Therapeutics, Inc. at 61 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.