Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06190093). StuddyBuddy aggregates publicly available trial information.