Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema (DIABEC)
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|ClinicalTrials.gov Identifier: NCT03598205|
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Combination Product: DIABEC plus intravitreal dexamethazone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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)|
|Actual Study Start Date :||February 5, 2018|
|Actual Primary Completion Date :||September 28, 2018|
|Actual Study Completion Date :||June 10, 2019|
Experimental: DIABEC plus intravitreal dexamethazone
Intervention:Curmin formulation (DIABEC) plus dexamethazone intravitreal injection. Oral curcumin formulation (DIABEC 2 tablets/die) in combination with Dexamethazone (0,7 mg) intravitral injection for diabetic macular edema treatment
Combination Product: DIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Other Name: Intravitreal dexamethazone
No Intervention: dexamethazone intravitreal injection
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.
- Mean difference in CRT from baseline to 6 months [ Time Frame: 6 months ]To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on OCT central retinal thickness after 6 months of therapy
- Mean difference in BCVA from baseline to 6 months [ Time Frame: 6 months ]To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on BCVA after 6 months of therapy
- Evaluation of safety: incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months
- Retreatment times [ Time Frame: 6 months ]To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598205
|Università Humanitas Gavazzeni Bergamo|
|Bergamo, Italy, 24125|
|Università degli Studi Magna Graecia|
|Catanzaro, Italy, 88100|
|Rome, Italy, 00198|
|Principal Investigator:||Mariacristina Parravano||Fondazione G.B. Bietti, IRCCS|