Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373659
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2006-09-07
Brief Title:
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Prospective Optical Coherence Tomography OCT Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab Lucentis PrONTO Study
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration AMD in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab PrONTO study
Detailed Description:
In this 2-year open-label prospective single-center uncontrolled investigator sponsored clinical study neovascular AMD patients with subfoveal CNV N40 and a central retinal thickness of at least 300 µm as measured by optical coherence tomography OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab 05 mg Thereafter retreatment with ranibizumab was performed if one of the following changes were observed between visits a loss of 5 letters in conjunction with fluid in the macula as detected by OCT an increase in OCT central retinal thickness of at least 100 μm new onset classic CNV new macular hemorrhage or persistent macular fluid following an injection of ranibizumab at the prior study visit
Study Oversight
Has Oversight DMC:
None
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?:
None