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Completed

NCT Number: NCT03598205

Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Humanitas Gavazzeni Bergamo, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIABEC plus intravitreal dexamethazone

Combination Product

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

Other names: Intravitreal dexamethazone

Primary outcomes

  1. Mean difference in CRT from baseline to 6 months

    Time frame: 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 outcomes

  1. Mean difference in BCVA from baseline to 6 months

    Time frame: 6 months

    To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on BCVA after 6 months of therapy

  2. Evaluation of safety: incidence of Treatment-Emergent Adverse Events

    Time frame: 6 months

    To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months

  3. Retreatment times

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Registry information

Official study title

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)

Acronym: DIABEC

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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