Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 153 for:    Enzyme | curcumin

Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema (DIABEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598205
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 25, 2018
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE February 5, 2018
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03598205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • 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
  • 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
  • Retreatment times [ Time Frame: 6 months ]
    To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • 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
  • Retreatment times [ Time Frame: 6 months ]
    To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
  • Evaluation of safety [ Time Frame: 6 months ]
    To explore the safety of curcumin formulation in addition to intravitreal dexamethasone therapy after 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE Combination Product: DIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Other Name: Intravitreal dexamethazone
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Combination Product: DIABEC plus intravitreal dexamethazone
  • No Intervention: dexamethazone intravitreal injection
    Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2018)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 10, 2019
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598205
Other Study ID Numbers  ICMJE FGBBietti
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS
Study Sponsor  ICMJE Fondazione G.B. Bietti, IRCCS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariacristina Parravano Fondazione G.B. Bietti, IRCCS
PRS Account Fondazione G.B. Bietti, IRCCS
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP