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
1 other identifier
interventional
61
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2018
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2020
CompletedMarch 19, 2025
March 1, 2025
1.8 years
February 14, 2019
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Baseline, 11 months
Secondary Outcomes (6)
Mean change in the best corrected visual acuity over time
Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
Baseline, 11 months
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
Baseline, 11 months
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Baseline, 11 months
- +1 more secondary outcomes
Study Arms (2)
bevacizumab
EXPERIMENTALONS-5010
ranibizumab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Clinical Site
Hurstville, New South Wales, Australia
Clinical Site
Liverpool, New South Wales, Australia
Clinical Site
Sydney, New South Wales, Australia
Clinical Site
Westmead, New South Wales, Australia
Clinical Site
Brisbane, Queensland, Australia
Clinical Site
Adelaide, South Australia, Australia
Clinical Site
Hobart, Tasmania, Australia
Clinical Site
Essendon, Victoria, Australia
Clinical Site
Glen Waverley, Victoria, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer M Kissner, PhD
Outlook Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 18, 2019
Study Start
October 1, 2018
Primary Completion
July 23, 2020
Study Completion
August 13, 2020
Last Updated
March 19, 2025
Record last verified: 2025-03