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Bevacizumab treatment for severe retinopathy of prematurity

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Phase 2 Interventional Jaeb Center for Health Research · NCT04634578

This study is testing if a lower dose of a medication called bevacizumab can effectively treat severe eye problems in premature infants just as well as the standard higher dose.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
AgesN/A to 6 Months
SexAll
SponsorJaeb Center for Health Research Academic / other
Drugs / interventionsbevacizumab
Locations26 sites (Little Rock, Arkansas and 25 other locations)
Trial IDNCT04634578 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of low-dose bevacizumab in treating type 1 retinopathy of prematurity (ROP) in infants. Participants will be randomly assigned to receive either 0.063 mg or 0.25 mg of intravitreous bevacizumab. The study will monitor treatment success, safety, and retinal vascularization over several follow-up visits, including assessments at 1 day, 4 days, and up to 4 months post-treatment. The primary goal is to determine if the lower dose can achieve similar outcomes to the standard dose in this severe condition.

Who should consider this trial

Good fit: Ideal candidates are infants with a birth weight less than 1251 grams who have been newly diagnosed with type 1 ROP in zone I.

Not a fit: Patients with previous treatment for ROP or those with advanced stages (4 or 5) of ROP will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for infants with severe ROP, potentially reducing the need for more invasive interventions.

How similar studies have performed: While the use of bevacizumab in ROP has been studied, this specific low-dose approach is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Little Rock, Arkansas and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Retinopathy of Prematurity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.