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

A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration

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.

Inclusion Criteria:

• Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye

• Best corrected visual acuity of 20/40 to 20/320

• Study eye must:

  • Have active leakage on Fluorescein Angiogram involving the fovea
  • Have edema involving the fovea
  • Be free of foveal scarring
  • Be free of foveal atrophy

Exclusion Criteria:

• Previous use of anti-VEGF or bevacizumab within 6 weeks
• 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) confirmed by indocyanine green angiography (ICGA)
• 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 or indocyanine green, not amenable to treatment