Age-related Macular DegenerationPhase 3NCT03844074
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
A Phase 3 study testing bevacizumab and ranibizumab in people with Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Outlook Therapeutics, Inc. at 9 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
- What is being tested?
- bevacizumab and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 9 sitesAustralia
- Study dates
- 1 Oct 2018to 13 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Clinical Site
Adelaide, South Australia
Clinical Site
Brisbane, Queensland
Clinical Site
Essendon, Victoria
Clinical Site
Glen Waverley, Victoria
Clinical Site
Hobart, Tasmania
Clinical Site
Hurstville, New South Wales
Clinical Site
Liverpool, New South Wales
Clinical Site
Sydney, New South Wales
Clinical Site
Westmead, New South Wales
About this study
Official 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
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.
- Conditions
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
- Being tested
- bevacizumab, ranibizumab
- Keywords
- Subfoveal Choroidal Neovascularization
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called ONS-5010
1.25 mg, intravitreal injection
ranibizumabBiological
0.5mg, intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | ONS-5010 Receives: Biological: bevacizumab |
| ranibizumab | Active comparator | Not described Receives: Biological: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 11 months
Secondary outcomes (6)
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.
Measured: Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Measured: Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Measured: Baseline, 11 months
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Measured: Baseline, 11 months
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Measured: Baseline, 11 months
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
Measured: 11 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Oct 2018
- Primary completion23 Jul 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outlook Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer M Kissner, PhD, Study director, Outlook Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844074
- Sponsor's protocol ID
- ONS-5010-001
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2019
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will not be shared until all global regulatory filings are complete.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03844074
- Acronym / sponsor ID
- ONS-5010-001
- Conditions
- Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
- Keywords
- Subfoveal Choroidal Neovascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Outlook Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Biological: bevacizumabONS-5010 |
| ranibizumab | Active comparator | Biological: ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabAlso: ONS-50101.25 mg, intravitreal injection | Biological | bevacizumab |
| ranibizumab0.5mg, intravitreal injection | Biological | ranibizumab |
Primary outcome
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
Time frame: Baseline, 11 months
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.
6 secondary outcomes
Mean change in the best corrected visual acuity over time
Time frame: Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
Time frame: Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
Time frame: Baseline, 11 months
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
Time frame: Baseline, 11 months
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Time frame: Baseline, 11 months
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
Time frame: 11 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided. Data will not be shared until all global regulatory filings are complete.
Related trials for Age-related Macular Degeneration
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Geographic Atrophy Secondary to Age-Related Macular Degeneration
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Enrolling by invitation
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Kissner, PhD study director
Outlook Therapeutics, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and ranibizumab in people with Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Outlook Therapeutics, Inc. at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score (time frame: Baseline, 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.