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Active, currently enrolling

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

NCT No.: NCT06190093

Study Type: Clinical Trial

Phase: Phase III

Region: California - Northern

Acronym: 

Official Title

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

Purpose

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

Detailed Description

Sex

Male & Female

Age Limit

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

Keywords and/or Specific Medical Conditions

  • Ophthalmology
  • Preventative Medicine

Sponsors

  • Outlook Therapeutics, Inc.

KP Clinical Facility

Clinical Area

  • Ophthalmology
  • Preventative Medicine

Principal Investigator

Robin Vora  

Contact Information

 - CTP Team
- ctpcollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

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