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Completed

NCT Number: NCT02164604

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

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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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Inselspital

Bern, Canton of Bern, 3001, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravitreal injection of 0.03ml ranibizumab

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Kantonsspital Aarau

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2014
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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