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New eye drug aims to save sight in wet AMD

NCT ID NCT06190093

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This trial tests whether an experimental drug called ONS-5010 (a form of bevacizumab) works as well as an approved drug, Lucentis, for treating wet age-related macular degeneration (AMD). Wet AMD causes rapid vision loss due to abnormal blood vessels leaking fluid in the eye. About 400 people with active wet AMD will receive injections of either ONS-5010 or Lucentis into the eye. The main goal is to see if ONS-5010 can prevent vision loss as effectively as Lucentis after 8 weeks of treatment.

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)
What this could lead to
If successful, this could offer a more affordable treatment option for wet age-related macular degeneration, helping preserve vision.
What could go wrong
This is a Phase 3 trial, so results are not yet confirmed. The drug may not prove as effective as Lucentis, and eye injections carry risks like infection or inflammation.

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

400 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2024

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 35-75 letters read (20/32 to 20/200 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 hemorrhage 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

    Arcadia, California, 91006, United States

  • Clinical Site

    Bakersfield, California, 93309, United States

  • Clinical Site

    Beverly Hills, California, 90210, United States

  • Clinical Site

    Huntington Beach, California, 92647, United States

  • Clinical Site

    Laguna Hills, California, 92653, United States

  • Clinical Site

    Long Beach, California, 90807, United States

  • Clinical Site

    Modesto, California, 95356, United States

  • Clinical Site

    Oakland, California, 94611, United States

  • Clinical Site

    Pasadena, California, 91107, United States

  • Clinical Site

    Poway, California, 92064, United States

  • Clinical Site

    Sacramento, California, 95841, United States

  • Clinical Site

    Colorado Springs, Colorado, 80909, United States

  • Clinical Site

    Lakewood, Colorado, 80228, United States

  • Clinical Site

    Waterford, Connecticut, 06385, United States

  • Clinical Site

    Coral Springs, Florida, 33067, United States

  • Clinical Site

    Fort Lauderdale, Florida, 33308, United States

  • Clinical Site

    Jacksonville, Florida, 32216, United States

  • Clinical Site

    Orlando, Florida, 32806, United States

  • Clinical Site

    Stuart, Florida, 34994, United States

  • Clinical Site

    Oak Forest, Illinois, 60452, United States

  • Clinical Site

    Oak Park, Illinois, 03440, United States

  • Clinical Site

    Carmel, Indiana, 46290, United States

  • Clinical Site

    Lenexa, Kansas, 66215, United States

  • Clinical Site

    Lexington, Kentucky, 40509, United States

  • Clinical Site

    Hagerstown, Maryland, 21740, United States

  • Clinical Site

    Edina, Minnesota, 55435, United States

  • Clinical Site

    Saint Louis Park, Minnesota, 55416, United States

  • Clinical Site

    Jackson, Mississippi, 39202, United States

  • Clinical Site

    Teaneck, New Jersey, 07666, United States

  • Clinical Site

    Albuquerque, New Mexico, 87109, United States

  • Clinical Site

    Liverpool, New York, 13088, United States

  • Clinical Site

    Oceanside, New York, 11572, United States

  • Clinical Site

    Rochester, New York, 14620, United States

  • Clinical Site

    Westbury, New York, 11590, United States

  • Clinical Site

    Asheville, North Carolina, 28803, United States

  • Clinical Site

    Hickory, North Carolina, 28602, United States

  • Clinical Site

    Wake Forest, North Carolina, 27587, United States

  • Clinical Site

    Winston-Salem, North Carolina, 27103, United States

  • Clinical Site

    Edmond, Oklahoma, 73013, United States

  • Clinical Site

    Charleston, South Carolina, 29414, United States

  • Clinical Site

    Florence, South Carolina, 29501, United States

  • Clinical Site

    Ladson, South Carolina, 29456, United States

  • Clinical Site

    West Columbia, South Carolina, 29169, 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

    Arlington, Texas, 76012, United States

  • Clinical Site

    Austin, Texas, 78705, United States

  • Clinical Site

    Beaumont, Texas, 77707, United States

  • Clinical Site

    Bellaire, Texas, 77401, United States

  • Clinical Site

    Dallas, Texas, 75231, United States

  • Clinical Site

    Round Rock, Texas, 78681, 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, 79606, United States

  • Clinical Site

    Salt Lake City, Utah, 84107, United States

  • Clinical Site

    Fairfax, Virginia, 22031, United States

  • Clinical Site

    Lynchburg, Virginia, 24502, United States

  • Clinical Site

    Bellevue, Washington, 98004, United States

  • Clinical Site

    Silverdale, Washington, 98383, United States

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