A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Completed · Phase 3
Conditions studied: Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT04516278
- Run by
- Outlook Therapeutics, Inc.
- People needed
- 197
- Starts
- 2020-10-01
- Expected to finish
- 2021-02-10
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Clinical Site — Tucson, Arizona, United States
- Clinical Site — Beverly Hills, California, United States
- Clinical Site — Glendale, California, United States
- Clinical Site — Long Beach, California, United States
- Clinical Site — Palm Desert, California, United States
- Clinical Site — Poway, California, United States
- Clinical Site — Clearwater, Florida, United States
- Clinical Site — Winter Haven, Florida, United States
- Clinical Site — Oak Forest, Illinois, United States
- Clinical Site — Springfield, Illinois, United States
- Clinical Site — Hagerstown, Maryland, United States
- Clinical Site — Albuquerque, New Mexico, United States
- Clinical Site — Chambersburg, Pennsylvania, United States
- Clinical Site — Rapid City, South Dakota, United States
- Clinical Site — Germantown, Tennessee, United States
- Clinical Site — Abilene, Texas, United States
- Clinical Site — Arlington, Texas, United States
- Clinical Site — McAllen, Texas, United States
- Clinical Site — San Antonio, Texas, United States
- Clinical Site — Willow Park, Texas, United States
Full record on ClinicalTrials.gov
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