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Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema (DIABEC)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DIABEC plus intravitreal dexamethazone
Sponsored by
Fondazione G.B. Bietti, IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Macular Edema focused on measuring Therapy for diabetic macular edema, Curcumin formulation (DIABEC)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Università Humanitas Gavazzeni Bergamo
  • Università degli Studi Magna Graecia
  • Fondazione G.B.Bietti-IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DIABEC plus intravitreal dexamethazone

dexamethazone intravitreal injection

Arm 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

Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2018
Last Updated
July 30, 2019
Sponsor
Fondazione G.B. Bietti, IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT03598205
Brief Title
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Acronym
DIABEC
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione G.B. Bietti, IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Therapy for diabetic macular edema, Curcumin formulation (DIABEC)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DIABEC plus intravitreal dexamethazone
Arm Type
Experimental
Arm 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
Arm Title
dexamethazone intravitreal injection
Arm Type
No Intervention
Arm Description
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.
Intervention Type
Combination Product
Intervention Name(s)
DIABEC plus intravitreal dexamethazone
Other Intervention Name(s)
Intravitreal dexamethazone
Intervention Description
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Primary Outcome Measure Information:
Title
Mean difference in CRT from baseline to 6 months
Description
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 Outcome Measure Information:
Title
Mean difference in BCVA from baseline to 6 months
Description
To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on BCVA after 6 months of therapy
Time Frame
6 months
Title
Evaluation of safety: incidence of Treatment-Emergent Adverse Events
Description
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
Title
Retreatment times
Description
To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariacristina Parravano
Organizational Affiliation
Fondazione G.B. Bietti, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Humanitas Gavazzeni Bergamo
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Università degli Studi Magna Graecia
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Fondazione G.B.Bietti-IRCCS
City
Rome
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

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