Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

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.

Despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe ROP, little is known about lower doses of bevacizumab for ROP. An increasing number of ophthalmologists are treating premature infants with severe ROP using bevacizumab. Given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. The proposed study will test progressively lower doses to find a dose to take forward to a future larger study.

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.