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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03844074




Registration number
NCT03844074
Ethics application status
Date submitted
14/02/2019
Date registered
18/02/2019

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)
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
Secondary ID [1] 0 0
ONS-5010-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration 0 0
Neovascular Age-related Macular Degeneration 0 0
Wet Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - bevacizumab
Treatment: Other - ranibizumab

Experimental: bevacizumab - ONS-5010

Active comparator: ranibizumab -


Treatment: Other: bevacizumab
1.25 mg, intravitreal injection

Treatment: Other: ranibizumab
0.5mg, intravitreal injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
Timepoint [1] 0 0
Baseline, 11 months
Secondary outcome [1] 0 0
Mean change in the best corrected visual acuity over time
Timepoint [1] 0 0
Baseline, monthly to 11 months
Secondary outcome [2] 0 0
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
Timepoint [2] 0 0
Baseline, 11 months
Secondary outcome [3] 0 0
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
Timepoint [3] 0 0
Baseline, 11 months
Secondary outcome [4] 0 0
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
Timepoint [4] 0 0
Baseline, 11 months
Secondary outcome [5] 0 0
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Timepoint [5] 0 0
Baseline, 11 months
Secondary outcome [6] 0 0
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
Timepoint [6] 0 0
11 months, 12 months

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/08/2020
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Clinical Site - Hurstville
Recruitment hospital [2] 0 0
Clinical Site - Liverpool
Recruitment hospital [3] 0 0
Clinical Site - Sydney
Recruitment hospital [4] 0 0
Clinical Site - Westmead
Recruitment hospital [5] 0 0
Clinical Site - Brisbane
Recruitment hospital [6] 0 0
Clinical Site - Adelaide
Recruitment hospital [7] 0 0
Clinical Site - Hobart
Recruitment hospital [8] 0 0
Clinical Site - Essendon
Recruitment hospital [9] 0 0
Clinical Site - Glen Waverley
Recruitment postcode(s) [1] 0 0
- Hurstville
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Hobart
Recruitment postcode(s) [8] 0 0
- Essendon
Recruitment postcode(s) [9] 0 0
- Glen Waverley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Outlook Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer M Kissner, PhD
Address 0 0
Outlook Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Data will not be shared until all global regulatory filings are complete.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03844074