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

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Drug: intravitreal injection of 0.03ml ranibizumab

• Registration Number: NCT02164604
• Lead Sponsor: Kantonsspital Aarau

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-05-22
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-16
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	intravitreal injection of 0.03ml ranibizumab	All eyes receive one intravitreal injection with 0.03ml ranibizumab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, Inselspital; 🇨🇭 Bern, Switzerland