Age-related Macular DegenerationPhase 3NCT04516278
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
A Phase 3 study testing bevacizumab in people with Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Outlook Therapeutics, Inc. at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Oct 2020to 10 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Clinical Site
Abilene, Texas, 79606
Clinical Site
Albuquerque, New Mexico, 87109
Clinical Site
Arlington, Texas, 76012
Clinical Site
Beverly Hills, California, 90211
Clinical Site
Chambersburg, Pennsylvania, 17201
Clinical Site
Clearwater, Florida, 33761
Clinical Site
Germantown, Tennessee, 38138
Clinical Site
Glendale, California, 91203
Clinical Site
Hagerstown, Maryland, 21740
Clinical Site
Long Beach, California, 90807
Clinical Site
McAllen, Texas, 78503
Clinical Site
Oak Forest, Illinois, 60452
Clinical Site
Palm Desert, California, 92260
Clinical Site
Poway, California, 92064
Clinical Site
Rapid City, South Dakota, 57701
Clinical Site
San Antonio, Texas, 78251
Clinical Site
Springfield, Illinois, 62704
Clinical Site
Tucson, Arizona, 85710
Clinical Site
Willow Park, Texas, 76087
Clinical Site
Winter Haven, Florida, 33880
About this study
Official title: 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.
- Conditions
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema
- Being tested
- bevacizumab
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration, Retinal Vein Occlusion
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
| Study group | Role | What they receive |
|---|---|---|
| Biological: bevacizumab | Experimental | ONS-5010 Receives: Biological: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants with adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Oct 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 197 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
- NCT04516278
- Sponsor's protocol ID
- ONS-5010-003
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2020
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE
- ClinicalTrials.gov ID
- NCT04516278
- Acronym / sponsor ID
- ONS-5010-003
- Conditions
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Outlook Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological: bevacizumab | Experimental | Biological: bevacizumabONS-5010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 | Biological: bevacizumab |
Primary outcome
Number of Participants With Adverse Events
Time frame: 3 months
Number of participants with adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
20 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 in people with Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Outlook Therapeutics, Inc. at 20 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 1 inclusion and 15 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 17 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 20 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 17 Jul 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?
Number of Participants With Adverse Events (time frame: 3 months). 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 17 Jul 2026.