Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

— DIABEC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598205
• Other study ID #: FGBBietti
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: July 2019
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 10, 2019
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• - Patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and OCT

• Naive patients

• Patients with clinically significant DME who have not been treated for more than 3 months with anti-VEGF therapy and for more than 6 months with intravitreal injection of dexamethasone

• Central retinal thickness (CRT) at OCT> 300 microns

• Best Corrected Visual Acuity (BCVA) with ETDRS tables at 4 meters not <20/400

• Ability to provide written informed consent and follow the procedures of the study

Exclusion Criteria:

• Retinal pathologies other than diabetic macular edema

• Proliferative diabetic retinopathy

• Opacities that limit the execution and interpretation of diagnostic tests

• Surgical interventions in the study eye in the 3 months prior to the start of treatment

• Pregnancy

• Feeding time

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Combination Product:
• DIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)

Locations

Country	Name	City	State
Italy	Università Humanitas Gavazzeni Bergamo	Bergamo
Italy	Università degli Studi Magna Graecia	Catanzaro
Italy	Fondazione G.B.Bietti-IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in CRT from baseline to 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	6 months
Secondary	Mean difference in BCVA from baseline to 6 months	To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on BCVA after 6 months of therapy	6 months
Secondary	Evaluation of safety: incidence of Treatment-Emergent Adverse Events	To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months	6 months
Secondary	Retreatment times	To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times	6 months