A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Completed · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration

In brief

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

Key facts

Study ID

NCT06190093

Run by

Outlook Therapeutics, Inc.

People needed

400

Starts

2024-01-24

Expected to finish

2024-12-05

Last updated by the study team

2026-07-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Bakersfield, California, United States
• Clinical Site — Beverly Hills, California, United States
• Clinical Site — Huntington Beach, California, United States
• Clinical Site — Laguna Hills, California, United States
• Clinical Site — Long Beach, California, United States
• Clinical Site — Modesto, California, United States
• Clinical Site — Oakland, California, United States
• Clinical Site — Pasadena, California, United States
• Clinical Site — Poway, California, United States
• Clinical Site — Sacramento, California, United States
• Clinical Site — Colorado Springs, Colorado, United States
• Clinical Site — Lakewood, Colorado, United States
• Clinical Site — Waterford, Connecticut, United States
• Clinical Site — Coral Springs, Florida, United States
• Clinical Site — Fort Lauderdale, Florida, United States
• Clinical Site — Jacksonville, Florida, United States
• Clinical Site — Orlando, Florida, United States
• Clinical Site — Stuart, Florida, United States
• Clinical Site — Oak Forest, Illinois, United States
• Clinical Site — Oak Park, Illinois, United States
• Clinical Site — Carmel, Indiana, United States
• Clinical Site — Lenexa, Kansas, United States
• Clinical Site — Lexington, Kentucky, United States
• Clinical Site — Hagerstown, Maryland, United States
• Clinical Site — Arcadia, California, United States

Full record on ClinicalTrials.gov

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