Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
intravitreal injection of 0.03ml ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring ranibizumab, intravitreal therapy, ROP, Plus disease, stage 3 plus
Eligibility 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
Sites / Locations
- Department of Ophthalmology, Inselspital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
All eyes receive one intravitreal injection with 0.03ml ranibizumab
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
number of patients with systemic side effects of intravitreal ranibizumab
number of patients with systemic side effects as a measure of safety.
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
Full Information
NCT ID
NCT02164604
First Posted
May 22, 2014
Last Updated
June 13, 2014
Sponsor
Kantonsspital Aarau
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02164604
Brief Title
Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
Official Title
Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
ranibizumab, intravitreal therapy, ROP, Plus disease, stage 3 plus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
All eyes receive one intravitreal injection with 0.03ml ranibizumab
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of 0.03ml ranibizumab
Primary Outcome Measure Information:
Title
number of eyes with ocular side effects due to intravitreal ranibizumab
Description
assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of patients with systemic side effects of intravitreal ranibizumab
Description
number of patients with systemic side effects as a measure of safety.
Time Frame
6 months
Title
efficacy of intravitreal ranibizumab to treat ROP stage 3 plus
Description
Assessment of the regression of ROP-related changes due to treatment as a measure for efficacy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Ophthalmology, Inselspital
City
Bern
ZIP/Postal Code
3001
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25886603
Citation
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.
Results Reference
derived
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Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
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