Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

• Status: Completed
• Trial end date: 2021-05-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.

• Phase: Phase 1
• 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:

1. Type 1 ROP; defined as:

• Zone I, any stage ROP with plus disease, or

• Zone I, stage 3 ROP without plus disease, or

• Zone II, stage 2 or 3 ROP with plus disease

2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

Exclusion Criteria:

The following exclusions apply to the study eye:

1. Nasolacrimal duct obstruction

2. Major ocular anomalies (e.g., cataract, coloboma)

3. Any opacity that precludes an adequate view of the retina

If purulent ocular discharge is present in either eye, then the infant is ineligible.