NCT02164604

Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease

Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Kantonsspital Aarau · Academic / Other
• Sex: All
• Age: 32 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

Summary

Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab. The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.

Detailed description

The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6 months.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	intravitreal injection of 0.03ml ranibizumab

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2014-06-16
• Last updated: 2014-06-16

Locations

1 site across 1 country: Switzerland