Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema (DIABEC)

F

Fondazione G.B. Bietti, IRCCS

Status

Completed

Conditions

Diabetic Macular Edema

Treatments

Combination Product: DIABEC plus intravitreal dexamethazone

Study type

Interventional

Funder types

Other

Identifiers

NCT03598205
FGBBietti

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

DIABEC plus intravitreal dexamethazone
Experimental group
Description:
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
Treatment:
Combination Product: DIABEC plus intravitreal dexamethazone
dexamethazone intravitreal injection
No Intervention group
Description:
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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