Retinopathy of Prematurity
Conditions
Keywords
ranibizumab, intravitreal therapy, ROP, Plus disease, stage 3 plus
Brief 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.
Interventions
DRUGintravitreal injection of 0.03ml ranibizumab
Sponsors
Insel Gruppe AG, University Hospital Bern
Kantonsspital Aarau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 40 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of eyes with ocular side effects due to intravitreal ranibizumab | 6 months | assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with systemic side effects of intravitreal ranibizumab | 6 months | number of patients with systemic side effects as a measure of safety. |
| efficacy of intravitreal ranibizumab to treat ROP stage 3 plus | 6 months | Assessment of the regression of ROP-related changes due to treatment as a measure for efficacy |
Countries
Switzerland
Outcome results
None listed