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

NCT02164604 | Completed

• 1 other identifier: KSA22-05-2014
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

ranibizumab; intravitreal therapy; ROP; Plus disease; stage 3 plus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• number of patients with systemic side effects of intravitreal ranibizumab

  6 months

• efficacy of intravitreal ranibizumab to treat ROP stage 3 plus

  6 months

Study Arms (1)

Ranibizumab

EXPERIMENTAL

All eyes receive one intravitreal injection with 0.03ml ranibizumab

Drug: intravitreal injection of 0.03ml ranibizumab

Interventions

intravitreal injection of 0.03ml ranibizumab DRUG

Ranibizumab

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ROP stage 3 plus disease

You may not qualify if:

• Severe systemic co-morbidity that did not allow systemic sedation for injection, or were antiVEGF (vascual endothelial growth factor) therapy was contra-indicated

Sponsors & Collaborators

• Kantonsspital Aarau: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Department of Ophthalmology, Inselspital

Bern, Canton of Bern, 3001, Switzerland

Location

Related Publications (1)

• Menke MN, Framme C, Nelle M, Berger MR, Sturm V, Wolf S. Intravitreal ranibizumab monotherapy to treat retinopathy of prematurity zone II, stage 3 with plus disease. BMC Ophthalmol. 2015 Mar 8;15:20. doi: 10.1186/s12886-015-0001-7.

  PMID: 25886603 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med univ. Marcel N Menke

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 16, 2014
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

CH (1)