Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
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|ClinicalTrials.gov Identifier: NCT02164604|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Drug: intravitreal injection of 0.03ml ranibizumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
All eyes receive one intravitreal injection with 0.03ml ranibizumab
Drug: intravitreal injection of 0.03ml ranibizumab
- number of eyes with ocular side effects due to intravitreal ranibizumab [ Time Frame: 6 months ]assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety
- number of patients with systemic side effects of intravitreal ranibizumab [ Time Frame: 6 months ]number of patients with systemic side effects as a measure of safety.
- efficacy of intravitreal ranibizumab to treat ROP stage 3 plus [ Time Frame: 6 months ]Assessment of the regression of ROP-related changes due to treatment as a measure for efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164604
|Department of Ophthalmology, Inselspital|
|Bern, Switzerland, 3001|