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Eye injection aims to tame leading causes of blindness

NCT ID NCT04516278

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests the safety of an experimental eye injection called ONS-5010 (bevacizumab) in people with vision loss from wet age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. Participants receive the injection and are monitored for side effects over three months. The goal is to see if this treatment is safe enough to move forward as a potential therapy for these common retinal conditions.

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 provide a safe, approved option for treating common causes of vision loss like wet AMD and diabetic macular edema.
What could go wrong
This is a safety-focused trial, so it won't prove how well the drug works. Side effects from eye injections, such as infection or inflammation, are possible.

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

197 people

The number who actually took part.

Started

Oct 2020

Finished

Feb 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

18 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 clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy Exclusion Criteria: * Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization * Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye * History of inadequate response to previous intravitreal anti-VEGF therapy * History of any intraocular or periocular corticosteroid injection or implant, 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 during the study period * Active intraocular inflammation in the study eye * Current vitreous hemorrhage in the study eye * Polypoidal choroidal vasculopathy (PCV) in the study eye * History of idiopathic, infectious or autoimmune-associated uveitis in either eye * Current ocular or periocular infection, such as 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 , not amenable to treatment

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration branch retinal artery occlusion diabetic macular edema macular degeneration occlusion of tributary of retinal vein retinal vein occlusion wet macular degeneration

As listed by the trial registrant

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

Age related macular degeneration Brvo - branch retinal vein occlusion Diabetic macular edema Neovascular age-related macular degeneration Wet macular degeneration

Contacts and locations

Locations

  • Clinical Site

    Tucson, Arizona, 85710, United States

  • Clinical Site

    Beverly Hills, California, 90211, United States

  • Clinical Site

    Glendale, California, 91203, United States

  • Clinical Site

    Long Beach, California, 90807, United States

  • Clinical Site

    Palm Desert, California, 92260, United States

  • Clinical Site

    Poway, California, 92064, United States

  • Clinical Site

    Clearwater, Florida, 33761, United States

  • Clinical Site

    Winter Haven, Florida, 33880, United States

  • Clinical Site

    Oak Forest, Illinois, 60452, United States

  • Clinical Site

    Springfield, Illinois, 62704, United States

  • Clinical Site

    Hagerstown, Maryland, 21740, United States

  • Clinical Site

    Albuquerque, New Mexico, 87109, United States

  • Clinical Site

    Chambersburg, Pennsylvania, 17201, 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

    McAllen, Texas, 78503, United States

  • Clinical Site

    San Antonio, Texas, 78251, United States

  • Clinical Site

    Willow Park, Texas, 76087, United States

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