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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Drug: intravitreal injection of 0.03ml ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br>All eyes receive one intravitreal injection with 0.03ml ranibizumab | Drug: intravitreal injection of 0.03ml ranibizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of eyes with ocular side effects due to intravitreal ranibizumab | assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with systemic side effects of intravitreal ranibizumab | number of patients with systemic side effects as a measure of safety. | 6 months | 
| efficacy of intravitreal ranibizumab to treat ROP stage 3 plus | Assessment of the regression of ROP-related changes due to treatment as a measure for efficacy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranibizumab, intravitreal therapy, ROP, Plus disease, stage 3 plus