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

• Status: Recruiting
• Trial end date: 2029-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI); Pediatric Eye Disease Investigator Group
• Treatments: Bevacizumab

Criteria

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