NCT02390531

Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Bevacizumab	Varying dosages in 10µl

Timeline

• Start date: 2015-04-28
• Primary completion: 2019-06-04
• Completion: 2021-05-11
• First posted: 2015-03-17
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

11 sites across 1 country: United States