Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Combination Product: DIABEC plus intravitreal dexamethazone

• Registration Number: NCT03598205
• Lead Sponsor: Fondazione G.B. Bietti, IRCCS

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-26
• Primary Completion: 2018-09-28
• Study Completion: 2019-06-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIABEC plus intravitreal dexamethazone	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

Primary Outcome Measures

Name	Time	Method
Mean difference in CRT from baseline to 6 months	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

Secondary Outcome Measures

Name	Time	Method
Retreatment times	6 months	To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
Mean difference in BCVA from baseline to 6 months	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	6 months	To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months

Trial Locations

Locations (3)

Università degli Studi Magna Graecia; 🇮🇹 Catanzaro, Italy

Università Humanitas Gavazzeni Bergamo; 🇮🇹 Bergamo, Italy

Fondazione G.B.Bietti-IRCCS; 🇮🇹 Rome, Italy