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Can a new eye injection save vision in wet AMD?

NCT ID NCT03834753

Disease control Sponsor: Outlook Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This clinical trial is testing whether an experimental eye injection called ONS-5010 (bevacizumab) can help preserve vision in people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The study will compare ONS-5010 to an existing treatment, ranibizumab, in about 228 participants. The main goal is to see if more people gain significant vision improvement with ONS-5010, while also checking its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bevacizumab (also called ONS-5010), given as an injection into the eye
What this could lead to
If successful, this could offer another treatment option to help preserve vision in people with wet age-related macular degeneration.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The treatment may not be as effective as the comparator, and eye injections carry risks like infection or retinal damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

228 people

The number who actually took part.

Started

Jun 2019

Finished

Jul 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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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Conditions

The condition(s) this trial relates to.

age-related macular degeneration macular degeneration wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age-related macular degeneration Neovascular age-related macular degeneration Wet macular degeneration

Contacts and locations

Locations

  • Clinical Site

    Tucson, Arizona, 85710, United States

  • Clinical Site

    Arcadia, California, 91007, United States

  • Clinical Site

    Beverly Hills, California, 90211, United States

  • Clinical Site

    Campbell, California, 95008, United States

  • Clinical Site

    Glendale, California, 91203, United States

  • Clinical Site

    Laguna Hills, California, 92653, United States

  • Clinical Site

    Long Beach, California, 90807, United States

  • Clinical Site

    Mountain View, California, 94040, United States

  • Clinical Site

    Oxnard, California, 93036, United States

  • Clinical Site

    Palm Desert, California, 92260, United States

  • Clinical Site

    Poway, California, 92064, United States

  • Clinical Site

    Sacramento, California, 95841, United States

  • Clinical Site

    Santa Maria, California, 93454, United States

  • Clinical Site

    Tustin, California, 92780, United States

  • Clinical Site

    Golden, Colorado, 80401, United States

  • Clinical Site

    Hamden, Connecticut, 06518, United States

  • Clinical Site

    Clearwater, Florida, 33761, United States

  • Clinical Site

    Pinellas Park, Florida, 33782, United States

  • Clinical Site

    Sarasota, Florida, 24233, United States

  • Clinical Site

    Winter Haven, Florida, 33880, United States

  • Clinical Site

    Augusta, Georgia, 30909, United States

  • Clinical Site

    Marietta, Georgia, 30060, United States

  • Clinical Site

    Downers Grove, Illinois, 60615, United States

  • Clinical Site

    Lemont, Illinois, 60439, United States

  • Clinical Site

    Springfield, Illinois, 62704, United States

  • Clinical Site

    Indianapolis, Indiana, 46290, United States

  • Clinical Site

    Hagerstown, Maryland, 21740, United States

  • Clinical Site

    Edina, Minnesota, 55435, United States

  • Clinical Site

    St Louis, Missouri, 63144, United States

  • Clinical Site

    Bloomfield, New Jersey, 07003, United States

  • Clinical Site

    Albuquerque, New Mexico, 87109, United States

  • Clinical Site

    New York, New York, 10021, United States

  • Clinical Site

    Chambersburg, Pennsylvania, 17201, United States

  • Clinical Site

    Monroeville, Pennsylvania, 15146, United States

  • Clinical Site

    Rapid City, South Dakota, 57701, United States

  • Clinical Site

    Germantown, Tennessee, 38138, United States

  • Clinical Site

    Abilene, Texas, 79606, United States

  • Clinical Site

    Amarillo, Texas, 79106, United States

  • Clinical Site

    Arlington, Texas, 76012, United States

  • Clinical Site

    Dallas, Texas, 75231, United States

  • Clinical Site

    Grapevine, Texas, 76051, United States

  • Clinical Site

    Houston, Texas, 77030, United States

  • Clinical Site

    McAllen, Texas, 78503, United States

  • Clinical Site

    San Antonio, Texas, 78240, United States

  • Clinical Site

    San Antonio, Texas, 78251, United States

  • Clinical Site

    The Woodlands, Texas, 77384, United States

  • Clinical Site

    Willow Park, Texas, 76807, United States

  • Clinical Site

    Salt Lake City, Utah, 84107, United States

  • Clinical Site

    Norfolk, Virginia, 23502, United States

  • Clinical Site

    Madison, Wisconsin, 53705, United States

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