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

Kantonsspital Aarau

Status

Completed

Conditions

Retinopathy of Prematurity

Treatments

Drug: intravitreal injection of 0.03ml ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02164604

KSA22-05-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

32 to 40 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

ROP stage 3 plus disease

Exclusion criteria

Severe systemic co-morbidity that did not allow systemic sedation for injection, or were antiVEGF (vascual endothelial growth factor) therapy was contra-indicated