Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Combination Product: DIABEC plus intravitreal dexamethazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIABEC plus intravitreal dexamethazone<br>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<br>* Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)<br>* Other names: Intravitreal dexamethazone;|
| No Intervention: dexamethazone intravitreal injection<br>Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Retreatment times | To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapy for diabetic macular edema, Curcumin formulation (DIABEC)