A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

Stopped early · Phase 3

Conditions studied: Retinopathy of Prematurity

In brief

This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

Key facts

Study ID

NCT04634604

Run by

Jaeb Center for Health Research

People needed

16

Starts

2022-04-27

Expected to finish

2023-08-14

Last updated by the study team

2026-06-17

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizonia Pediatric Eye Specialists — Phoenix, Arizona, United States
• Arkansas Childrens Hospital/ University of Arkansas Medical Sciences — Little Rock, Arkansas, United States
• Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California San Francisco Department of Ophthalmology — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Connecticut Childrens Medical Center — Farmington, Connecticut, United States
• The Emory Eye Center — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• U of Illinois at Chicago Eye and Ear Infirmary — Chicago, Illinois, United States
• University of Chicago — Hyde Park, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• UK Ophthalmology and Visual Sciences, The Eye Clinic — Lexington, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Missouri- Columbia Mason Eye Institute — Columbia, Missouri, United States
• St. Louis University Ophthalmology — St Louis, Missouri, United States
• Children's Hospital & Medical Center — Omaha, Nebraska, United States
• New York Presbyterian David H Koch Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Eye Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Pediatric Ophthalmology Associates, Inc. — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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