Status:
COMPLETED
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Lead Sponsor:
Outlook Therapeutics, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
Eligibility Criteria
Inclusion
- Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
- Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
- Study eye must:
- Have active leakage on Fluorescein Angiogram involving the fovea
- Have edema involving the fovea
- Be free of scarring, fibrosis, or atrophy involving the central foveal zone
Exclusion
- Previous subfoveal focal laser photocoagulation 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 within 1 year
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- Polypoidal choroidal vasculopathy (PCV) in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Infectious 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 or history of allergy to fluorescein , not amenable to treatment
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06190093
Start Date
January 24 2024
End Date
December 5 2024
Last Update
February 25 2025
Active Locations (61)
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1
Clinical Site
Arcadia, California, United States, 91006
2
Clinical Site
Bakersfield, California, United States, 93309
3
Clinical Site
Beverly Hills, California, United States, 90210
4
Clinical Site
Huntington Beach, California, United States, 92647