Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

Fondazione G.B. Bietti, IRCCS72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

DIABEC plus intravitreal dexamethazoneCOMBINATION_PRODUCT

Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

Università Humanitas Gavazzeni Bergamo

Bergamo, Italy

Università degli Studi Magna Graecia

Catanzaro, Italy

Fondazione G.B.Bietti-IRCCS

Rome, Italy

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 6 months

Retreatment times

To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times

Time frame: 6 months

Data from ClinicalTrials.gov

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