NCT03598205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

July 13, 2018

Last Update Submit

July 30, 2019

Conditions

Diabetic Macular Edema

Keywords

Therapy for diabetic macular edemaCurcumin formulation (DIABEC)

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • Mean difference in BCVA from baseline to 6 months

    6 months

  • Evaluation of safety: incidence of Treatment-Emergent Adverse Events

    6 months

  • Retreatment times

    6 months

Study Arms (2)

DIABEC plus intravitreal dexamethazone

EXPERIMENTAL

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

dexamethazone intravitreal injection

NO INTERVENTION

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

Interventions

DIABEC plus intravitreal dexamethazoneCOMBINATION_PRODUCT

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

Also known as: Intravitreal dexamethazone
DIABEC plus intravitreal dexamethazone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Università Humanitas Gavazzeni Bergamo

Bergamo, 24125, Italy

Location

Università degli Studi Magna Graecia

Catanzaro, 88100, Italy

Location

Fondazione G.B.Bietti-IRCCS

Rome, 00198, Italy

Location

Study Officials

  • Mariacristina Parravano

    Fondazione G.B. Bietti, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD , Head RETINA UNIT

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 26, 2018

Study Start

February 5, 2018

Primary Completion

September 28, 2018

Study Completion

June 10, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

IT(3)