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Tiny doses of avastin tested against laser for preemie eye disease

NCT ID NCT04634604

Disease control Sponsor: Jaeb Center for Health Research 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tested a low dose of the drug bevacizumab (Avastin) against standard laser treatment for retinopathy of prematurity, an eye disease that can blind premature infants. Sixteen babies with severe disease were enrolled. The goal was to see if the drug could control the disease as well as laser, but the trial was stopped early, so the results are not conclusive.

What this could mean

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

Active substance
bevacizumab (Avastin)
What this could lead to
If successful, this could offer a less invasive treatment option for retinopathy of prematurity, potentially reducing side effects compared to laser.
What could go wrong
The trial was terminated early with only 16 participants, so results are very limited. It is unclear if low-dose bevacizumab is as effective as laser, and there may be unknown risks.

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

16 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 6 months

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: * Birth weight \< 1251 grams * Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria: * Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or * Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or * Zone II, stage 2 or 3 ROP with plus disease Exclusion Criteria: * Previous treatment for ROP * Stage 4 or 5 ROP in either eye * All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant) * Either treatment could not be done within 2 days of diagnosis of type 1 ROP * Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment * Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks * Active ocular infection or purulent nasolacrimal duct obstruction in either eye One eye will be excluded, and other eye may be eligible, if either of the following are present: * Visually significant ocular anomaly (e.g., cataract, coloboma) * Opacity that precludes an adequate view of the retina

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

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

Retinopathy of prematurity

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Arizonia Pediatric Eye Specialists

    Phoenix, Arizona, 85006, United States

  • Arkansas Childrens Hospital/ University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02215, United States

  • CHU - Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Children's Hospital & Medical Center

    Omaha, Nebraska, 68114, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Connecticut Childrens Medical Center

    Farmington, Connecticut, 06032, United States

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204, United States

  • Duke University Eye Center

    Durham, North Carolina, 27710, United States

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204-5809, United States

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • New York Presbyterian David H Koch Center

    New York, New York, 10065, United States

  • Pediatric Ophthalmology Associates, Inc.

    Columbus, Ohio, 43205, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • St. Louis University Ophthalmology

    St Louis, Missouri, 63104, United States

  • Storm Eye Institute

    Mt. Pleasant, South Carolina, 29464, United States

  • Texas Children's Hospital - Dept. Of Ophthalmology

    Houston, Texas, 77030, United States

  • The Emory Eye Center

    Atlanta, Georgia, 30322, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • The Woman's Hospital of Texas

    Houston, Texas, 77054, United States

  • U of Illinois at Chicago Eye and Ear Infirmary

    Chicago, Illinois, 60612, United States

  • UK Ophthalmology and Visual Sciences, The Eye Clinic

    Lexington, Kentucky, 40508, United States

  • UPMC Children's Eye Center of Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Univ of California, Irvine- Gavin Herbert Eye Institute

    Irvine, California, 92697, United States

  • University of California San Francisco Department of Ophthalmology

    San Francisco, California, 94143, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of Chicago

    Hyde Park, Illinois, 60637, United States

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045, United States

  • University of Missouri- Columbia Mason Eye Institute

    Columbia, Missouri, 65201, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Utah Moran Eye Center

    Salt Lake City, Utah, 84132, United States

  • Virginia Pediatric Eye Center

    Norfolk, Virginia, 23502, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.