Status:
COMPLETED
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Lead Sponsor:
Outlook Therapeutics, Inc.
Conditions:
Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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: exu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04516278
Start Date
October 1 2020
End Date
February 10 2021
Last Update
March 19 2025
Active Locations (20)
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1
Clinical Site
Tucson, Arizona, United States, 85710
2
Clinical Site
Beverly Hills, California, United States, 90211
3
Clinical Site
Glendale, California, United States, 91203
4
Clinical Site
Long Beach, California, United States, 90807