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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03834753
Registration number
NCT03834753
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019
Date last updated
17/02/2022
Titles & IDs
Public title
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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Scientific title
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
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Secondary ID [1]
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ONS-5010-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration
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Neovascular Age-related Macular Degeneration
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Wet Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - bevacizumab
Other interventions - ranibizumab
Experimental: bevacizumab - ONS-5010
Active Comparator: ranibizumab -
Other interventions: bevacizumab
1.25 mg, intravitreal injection
Other interventions: ranibizumab
0.5mg, intravitreal injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, 11 months
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Secondary outcome [1]
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Mean change in the best corrected visual acuity
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Assessment method [1]
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BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
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Timepoint [1]
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Baseline, monthly to 11 months
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Secondary outcome [2]
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Proportion of participants who gain at least 10 letters in the best corrected visual acuity
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Assessment method [2]
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BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
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Timepoint [2]
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Baseline, 11 months
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Secondary outcome [3]
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Proportion of participants who gain at least 5 letters in the best corrected visual acuity
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Assessment method [3]
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BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
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Timepoint [3]
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Baseline, 11 months
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Secondary outcome [4]
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Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity
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Assessment method [4]
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BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
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Timepoint [4]
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Baseline, 11 months
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Secondary outcome [5]
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Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
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Assessment method [5]
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Timepoint [5]
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Baseline, 11 months
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Secondary outcome [6]
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Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
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Assessment method [6]
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Timepoint [6]
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11 months, 12 months
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Eligibility
Key inclusion criteria
- 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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/07/2021
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Sample size
Target
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Accrual to date
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Final
228
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Maryland
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Minnesota
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Missouri
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New Jersey
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New Mexico
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New York
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Outlook Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03834753
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Jennifer M Kissner, PhD
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Address
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Outlook Therapeutics, Inc.
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03834753
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