NCT05112861Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Oct 2021
- Start date
- 15 Nov 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- Outlook Therapeutics, Inc.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT05112861
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 15 Nov 2021 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
- Previous use of Beovu®
- History of inadequate response to previous intravitreal anti-VEGF therapy
- Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
Other illness
- History of any intraocular or periocular corticosteroid injection or implant, in the study eye
- Current vitreous hemorrhage 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
- Current treatment for active systemic infection
- Known allergy to any component of the study drug , not amenable to treatment
Other
- Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
- Active intraocular inflammation in the study eye
- Polypoidal choroidal vasculopathy (PCV) in the study eye
- Premenopausal women not using adequate contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chambersburg | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.