Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT02134457
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2014-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity
Sponsor:
University Hospital Freiburg
Organization:
Study Overview
Official Title:
Multicenter Randomized Double Masked Parallel Design Exploratory Study to Assess Safety and Efficacy of Two Different Doses of Intravitreal Anti-VEGF Treatment With Ranibizumab (0.12 mg vs. 0.20 mg) in Infants With Retinopathy of Prematurity (ROP)
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-ROP
Brief Summary:
This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates.
The primary objective is to assess clinical efficacy of ranibizumab in children with ROP
The primary objective is to assess clinical efficacy of ranibizumab in children with ROP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002539-13 | EUDRACT_NUMBER | None | View |