Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-01-09 @ 7:10 AM
Study NCT ID:
NCT03598205
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Sponsor:
Fondazione G.B. Bietti, IRCCS
Organization:
Study Overview
Official Title:
Combination Therapy Based on Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema Treatment to Help the Antiedemigenous Effect of Intravitreal Dexamethasone in Subjects With Diabetic Macular Edema (DME)
Status:
COMPLETED
Status Verified Date:
2019-07
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:
DIABEC
Brief Summary:
The aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.
Detailed Description:
Patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled in the study.
Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.
The enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.
Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.
The enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: