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

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ClinicalTrials.gov Identifier: NCT02164604
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Marcel Menke, Kantonsspital Aarau

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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: intravitreal injection of 0.03ml ranibizumab Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease
Study Start Date : January 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab
All eyes receive one intravitreal injection with 0.03ml ranibizumab
Drug: intravitreal injection of 0.03ml ranibizumab



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164604


Locations
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Switzerland
Department of Ophthalmology, Inselspital
Bern, Switzerland, 3001
Sponsors and Collaborators
Kantonsspital Aarau
University Hospital Inselspital, Berne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcel Menke, PD Dr. med univ. Marcel N Menke, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT02164604     History of Changes
Other Study ID Numbers: KSA22-05-2014
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Marcel Menke, Kantonsspital Aarau:
ranibizumab
intravitreal therapy
ROP
Plus disease
stage 3 plus
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents