A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04516278 |
Recruitment Status :
Completed
First Posted : August 18, 2020
Last Update Posted : November 19, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration BRVO - Branch Retinal Vein Occlusion Diabetic Macular Edema | Biological: bevacizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 195 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE |
Actual Study Start Date : | October 1, 2020 |
Actual Primary Completion Date : | February 10, 2021 |
Actual Study Completion Date : | February 10, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Biological: bevacizumab
ONS-5010
|
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Name: ONS-5010 |
- Frequency and incidence of treatment-emergent adverse events [ Time Frame: 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516278
United States, Arizona | |
Clinical Site | |
Tucson, Arizona, United States, 85710 | |
United States, California | |
Clinical Site | |
Beverly Hills, California, United States, 90211 | |
Clinical Site | |
Glendale, California, United States, 91203 | |
Clinical Site | |
Long Beach, California, United States, 90807 | |
Clinical Site | |
Palm Desert, California, United States, 92260 | |
Clinical Site | |
Poway, California, United States, 92064 | |
United States, Florida | |
Clinical Site | |
Clearwater, Florida, United States, 33761 | |
Clinical Site | |
Winter Haven, Florida, United States, 33880 | |
United States, Illinois | |
Clinical Site | |
Oak Forest, Illinois, United States, 60452 | |
Clinical Site | |
Springfield, Illinois, United States, 62704 | |
United States, Maryland | |
Clinical Site | |
Hagerstown, Maryland, United States, 21740 | |
United States, New Mexico | |
Clinical Site | |
Albuquerque, New Mexico, United States, 87109 | |
United States, Pennsylvania | |
Clinical Site | |
Chambersburg, Pennsylvania, United States, 17201 | |
United States, South Dakota | |
Clinical Site | |
Rapid City, South Dakota, United States, 57701 | |
United States, Tennessee | |
Clinical Site | |
Germantown, Tennessee, United States, 38138 | |
United States, Texas | |
Clinical Site | |
Abilene, Texas, United States, 79606 | |
Clinical Site | |
Arlington, Texas, United States, 76012 | |
Clinical Site | |
McAllen, Texas, United States, 78503 | |
Clinical Site | |
San Antonio, Texas, United States, 78251 | |
Clinical Site | |
Willow Park, Texas, United States, 76087 |
Responsible Party: | Outlook Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04516278 |
Other Study ID Numbers: |
ONS-5010-003 |
First Posted: | August 18, 2020 Key Record Dates |
Last Update Posted: | November 19, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Vision Disorders Vision, Low Macular Degeneration Macular Edema Retinal Vein Occlusion Wet Macular Degeneration Retinal Diseases Retinal Degeneration Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |