Ignite Creation Date:
2024-05-06 @ 2:46 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02127684
Status:
WITHDRAWN
Last Update Posted:
2014-07-30
First Post:
2014-04-29
Brief Title:
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing
Sponsor:
Maturi Raj K MD PC
Organization:
Maturi Raj K MD PC
Study Overview
Official Title:
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing
Status:
WITHDRAWN
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor determined study design would not produce useful results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen
Detailed Description:
This is an open-label subject masked phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months Consented enrolled subjects will be randomized into two subgroups 1 standard dosing of monthly 03mg ranibizumab or 2 03mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing
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