A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
1 other identifier
interventional
195
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2020
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 18, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2021
CompletedMarch 19, 2025
March 1, 2025
4 months
August 13, 2020
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency and incidence of treatment-emergent adverse events
3 months
Study Arms (1)
Biological: bevacizumab
EXPERIMENTALONS-5010
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Clinical Site
Tucson, Arizona, 85710, United States
Clinical Site
Beverly Hills, California, 90211, United States
Clinical Site
Glendale, California, 91203, United States
Clinical Site
Long Beach, California, 90807, United States
Clinical Site
Palm Desert, California, 92260, United States
Clinical Site
Poway, California, 92064, United States
Clinical Site
Clearwater, Florida, 33761, United States
Clinical Site
Winter Haven, Florida, 33880, United States
Clinical Site
Oak Forest, Illinois, 60452, United States
Clinical Site
Springfield, Illinois, 62704, United States
Clinical Site
Hagerstown, Maryland, 21740, United States
Clinical Site
Albuquerque, New Mexico, 87109, United States
Clinical Site
Chambersburg, Pennsylvania, 17201, 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
McAllen, Texas, 78503, United States
Clinical Site
San Antonio, Texas, 78251, United States
Clinical Site
Willow Park, Texas, 76087, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2020
First Posted
August 18, 2020
Study Start
October 1, 2020
Primary Completion
February 10, 2021
Study Completion
February 10, 2021
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share