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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03834753




Registration number
NCT03834753
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019
Date last updated
27/06/2019

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-5010-002
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
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change from baseline in best corrected visual acuity (BCVA) - 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.
Timepoint [1] 0 0
Baseline, 11 months
Secondary outcome [1] 0 0
Proportion of participants who gain at least 5 letters in the best corrected visual acuity - BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Timepoint [1] 0 0
Baseline, 11 months
Secondary outcome [2] 0 0
Proportion of participants who gain at least 10 letters in the best corrected visual acuity - BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Timepoint [2] 0 0
Baseline, 11 months
Secondary outcome [3] 0 0
Proportion of participants who gain at least 15 letters in the best corrected visual acuity - BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Timepoint [3] 0 0
Baseline, 11 months
Secondary outcome [4] 0 0
Mean change in the best corrected visual acuity over time - BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Timepoint [4] 0 0
Baseline, monthly to 11 months
Secondary outcome [5] 0 0
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity - BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Timepoint [5] 0 0
Baseline, 11 months
Secondary outcome [6] 0 0
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Timepoint [6] 0 0
Baseline, 11 months
Secondary outcome [7] 0 0
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
Timepoint [7] 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 25-60 letters read (20/60 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 foveal scarring

- Be free of foveal atrophy
Minimum age
50 Years
Maximum age
No limit
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
Clinical Site - Canberra
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 - Adelaide
Recruitment hospital [6] 0 0
Clinical Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Canberra
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
- Adelaide
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Christchurch

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03834753
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
Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+1 (609) 619-3984
Fax 0 0
Email 0 0
ClinicalStudies@outlooktherapeutics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03834753