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

Retinopathy of Prematurity Clinical Trial

Official title:

Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164604
• Other study ID #: KSA22-05-2014
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: June 13, 2014
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: National Health Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 40 Weeks

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• intravitreal injection of 0.03ml ranibizumab

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Aarau	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	number of patients with systemic side effects of intravitreal ranibizumab	number of patients with systemic side effects as a measure of safety.	6 months	No
Secondary	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	No