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Can a lower dose of avastin save sight in preemies?

NCT ID NCT04634578

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether lower doses of the drug bevacizumab (Avastin) can effectively treat a severe form of retinopathy of prematurity (ROP) in premature infants. The trial includes 77 babies with type 1 ROP in zone I, the most dangerous type. Each infant receives a single injection of either 0.063 mg or 0.25 mg of bevacizumab into the affected eye(s). The main goal is to see if the disease improves within 4 weeks without needing additional 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 (Avastin) injection into the eye
What this could lead to
If successful, this could show that lower doses of bevacizumab are effective for severe ROP, potentially reducing side effects while still saving sight.
What could go wrong
This is a small Phase 2 trial with only 77 infants, so results may not apply to all cases. Lower doses might not work as well as standard doses, and recurrence of ROP is 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

77 people

The number who actually took part.

Started

May 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

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: The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate: 1. Birth weight \< 1251 grams 2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes Exclusion Criteria: Participants meeting any of the following exclusion criteria will be excluded from study participation. 1. Previous treatment for ROP 2. Stage 4 or 5 ROP in either eye 3. Treatment could not be done within 2 days of diagnosis of type 1 ROP 4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment 5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits. 6. 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

  • Arkansas Childrens Hospital/ University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02215, United States

  • Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, 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

  • Jules Stein Eye Institute at the University of California, Los Angeles

    Los Angeles, California, 90095, 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

  • 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

  • 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 Utah Moran Eye Center

    Salt Lake City, Utah, 84132, United States

  • Virginia Pediatric Eye Center

    Norfolk, Virginia, 23502, United States

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