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Age-related Macular DegenerationPhase 3NCT03834753

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 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
228 participants
Where
50 sitesUnited States
Study dates
25 Jun 2019to 8 Jul 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Clinical Site

    Abilene, Texas, 79606

  • Clinical Site

    Albuquerque, New Mexico, 87109

  • Clinical Site

    Amarillo, Texas, 79106

  • Clinical Site

    Arcadia, California, 91007

  • Clinical Site

    Arlington, Texas, 76012

  • Clinical Site

    Augusta, Georgia, 30909

  • Clinical Site

    Beverly Hills, California, 90211

  • Clinical Site

    Bloomfield, New Jersey, 07003

  • Clinical Site

    Campbell, California, 95008

  • Clinical Site

    Chambersburg, Pennsylvania, 17201

  • Clinical Site

    Clearwater, Florida, 33761

  • Clinical Site

    Dallas, Texas, 75231

  • Clinical Site

    Downers Grove, Illinois, 60615

  • Clinical Site

    Edina, Minnesota, 55435

  • Clinical Site

    Germantown, Tennessee, 38138

  • Clinical Site

    Glendale, California, 91203

  • Clinical Site

    Golden, Colorado, 80401

  • Clinical Site

    Grapevine, Texas, 76051

  • Clinical Site

    Hagerstown, Maryland, 21740

  • Clinical Site

    Hamden, Connecticut, 06518

  • Clinical Site

    Houston, Texas, 77030

  • Clinical Site

    Indianapolis, Indiana, 46290

  • Clinical Site

    Laguna Hills, California, 92653

  • Clinical Site

    Lemont, Illinois, 60439

  • Clinical Site

    Long Beach, California, 90807

  • Clinical Site

    Madison, Wisconsin, 53705

  • Clinical Site

    Marietta, Georgia, 30060

  • Clinical Site

    McAllen, Texas, 78503

  • Clinical Site

    Monroeville, Pennsylvania, 15146

  • Clinical Site

    Mountain View, California, 94040

  • Clinical Site

    New York, New York, 10021

  • Clinical Site

    Norfolk, Virginia, 23502

  • Clinical Site

    Oxnard, California, 93036

  • Clinical Site

    Palm Desert, California, 92260

  • Clinical Site

    Pinellas Park, Florida, 33782

  • Clinical Site

    Poway, California, 92064

  • Clinical Site

    Rapid City, South Dakota, 57701

  • Clinical Site

    Sacramento, California, 95841

  • Clinical Site

    Salt Lake City, Utah, 84107

  • Clinical Site

    San Antonio, Texas, 78240

  • Clinical Site

    San Antonio, Texas, 78251

  • Clinical Site

    Santa Maria, California, 93454

  • Clinical Site

    Sarasota, Florida, 24233

  • Clinical Site

    Springfield, Illinois, 62704

  • Clinical Site

    St Louis, Missouri, 63144

  • Clinical Site

    The Woodlands, Texas, 77384

  • Clinical Site

    Tucson, Arizona, 85710

  • Clinical Site

    Tustin, California, 92780

  • Clinical Site

    Willow Park, Texas, 76807

  • Clinical Site

    Winter Haven, Florida, 33880

Other trials in United States

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.

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 groups in NCT03834753
Study groupRoleWhat they receive
bevacizumabExperimentalONS-5010
Receives: Biological: bevacizumab
ranibizumabActive comparatorNot described
Receives: Biological: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Who Gain 15 or More Letters 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.

    Measured: 11 months

Secondary outcomes (5)

  1. Mean Change 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.

    Measured: 11 months

  2. 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.

    Measured: 11 months

  3. 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.

    Measured: 11 months

  4. 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.

    Measured: 11 months

  5. Proportion of Participants With Visual-acuity Snellen Equivalent of 20/200 or Worse

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start25 Jun 2019
  3. Primary completion7 Jun 2021
  4. Study completion8 Jul 2021

Resources

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
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834753
Sponsor's protocol ID
ONS-5010-002
Status last verified
Jul 2026
First submitted
6 Feb 2019
Last updated
3 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Data will not be shared until all global regulatory filings are complete.

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 50 sites in United States.

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 6 inclusion and 12 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. 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?

Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Best Corrected Visual Acuity (BCVA) (time frame: 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834753.

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 3 Aug 2026.

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