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Completed
NCT06190093
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Conditions: Neovascular Age-related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 400
Sponsor: Outlook Therapeutics, Inc.
Location: Clinical Site Arcadia California
Summary
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT06190093). StuddyBuddy aggregates publicly available trial information.