Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 6:36 PM
Study NCT ID:
NCT01934556
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
Sponsor:
Palmetto Retina Center, LLC
Organization:
Study Overview
Official Title:
A Phase I/II, Open Label, Multicenter, Randomized, Controlled Study of the Safety, Tolerability and Efficacy of Intravitreal Injections of 0.3 mg Ranibizumab Given Monthly Compared to a TReat and EXtend Protocol in Patients With Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2020-10
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:
TREX-DME
Brief Summary:
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.
Detailed Description:
This research study will compare the visual outcomes between a group of patients who are treated with monthly injections of Ranibizumab 0.3 mg and two groups of patients who are treated with the "Treat and Extend" regimen. One of the "Treat and Extend" groups will also receive laser therapy to determine if this has any additional beneficial effects.
Study Oversight
Has Oversight DMC:
False
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?: