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

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Combination Product: DIABEC plus intravitreal dexamethazone Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Curcumin

Arm Intervention/treatment
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
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

No Intervention: dexamethazone intravitreal injection
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598205


Locations
Layout table for location information
Italy
Università Humanitas Gavazzeni Bergamo
Bergamo, Italy, 24125
Università degli Studi Magna Graecia
Catanzaro, Italy, 88100
Fondazione G.B.Bietti-IRCCS
Rome, Italy, 00198
Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS
Investigators
Layout table for investigator information
Principal Investigator: Mariacristina Parravano Fondazione G.B. Bietti, IRCCS

Layout table for additonal information
Responsible Party: Mariacristina Parravano, MD , Head RETINA UNIT, Fondazione G.B. Bietti, IRCCS
ClinicalTrials.gov Identifier: NCT03598205     History of Changes
Other Study ID Numbers: FGBBietti
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS:
Therapy for diabetic macular edema
Curcumin formulation (DIABEC)

Additional relevant MeSH terms:
Layout table for MeSH terms
Enzyme Inhibitors
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Curcumin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents