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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-10-31

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.

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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.

Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab

All eyes receive one intravitreal injection with 0.03ml ranibizumab

Group Type EXPERIMENTAL

intravitreal injection of 0.03ml ranibizumab

Intervention Type DRUG

Interventions

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intravitreal injection of 0.03ml ranibizumab

Intervention Type DRUG

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

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No