Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

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)

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.

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.

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