A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Completed · Phase 3

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

In brief

This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.

Key facts

Study ID

NCT03834753

Run by

Outlook Therapeutics, Inc.

People needed

228

Starts

2019-06-25

Expected to finish

2021-07-08

Last updated by the study team

2026-08-03

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 25-67 letters read (20/50 to 20/320 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 haemorrhage 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 — Tucson, Arizona, United States
• Clinical Site — Arcadia, California, United States
• Clinical Site — Beverly Hills, California, United States
• Clinical Site — Campbell, California, United States
• Clinical Site — Glendale, California, United States
• Clinical Site — Laguna Hills, California, United States
• Clinical Site — Long Beach, California, United States
• Clinical Site — Mountain View, California, United States
• Clinical Site — Oxnard, California, United States
• Clinical Site — Palm Desert, California, United States
• Clinical Site — Poway, California, United States
• Clinical Site — Sacramento, California, United States
• Clinical Site — Santa Maria, California, United States
• Clinical Site — Tustin, California, United States
• Clinical Site — Golden, Colorado, United States
• Clinical Site — Hamden, Connecticut, United States
• Clinical Site — Clearwater, Florida, United States
• Clinical Site — Pinellas Park, Florida, United States
• Clinical Site — Sarasota, Florida, United States
• Clinical Site — Winter Haven, Florida, United States
• Clinical Site — Augusta, Georgia, United States
• Clinical Site — Marietta, Georgia, United States
• Clinical Site — Downers Grove, Illinois, United States
• Clinical Site — Lemont, Illinois, United States
• Clinical Site — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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