Trial | NCT03844074  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
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.
Study Started
Oct 01
2018
Primary Completion
Jul 23
2020
Study Completion
Aug 13
2020
Last Update
May 12
2021

Biological bevacizumab

1.25 mg, intravitreal injection

  • Other names: ONS-5010

Biological ranibizumab

0.5mg, intravitreal injection

bevacizumab Experimental

ONS-5010

ranibizumab Active Comparator

Criteria 

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
No Results Posted