Diabetic Macular EdemaDIABECNCT03598205
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
A study testing DIABEC plus intravitreal dexamethazone in people with Diabetic Macular Edema, run by Fondazione G.B. Bietti, IRCCS at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- DIABEC plus intravitreal dexamethazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Feb 2018to 10 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Università Humanitas Gavazzeni Bergamo
Bergamo, 24125
Università degli Studi Magna Graecia
Catanzaro, 88100
Fondazione G.B.Bietti-IRCCS
Rome, 00198
About this study
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)
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.
Read the 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.
- Conditions
- Diabetic Macular Edema
- Being tested
- DIABEC plus intravitreal dexamethazone
- Keywords
- Therapy for diabetic macular edema, Curcumin formulation (DIABEC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIABEC plus intravitreal dexamethazoneCombination product
Also called Intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
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
Measured: 6 months
Retreatment times
To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start5 Feb 2018
- Primary completion28 Sep 2018
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS
- Investigators
- Mariacristina Parravano, Principal investigator, Fondazione G.B. Bietti, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598205
- Sponsor's protocol ID
- FGBBietti
- Acronym
- DIABEC
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03598205
- Acronym / sponsor ID
- DIABEC / FGBBietti
- Conditions
- Diabetic Macular Edema
- Keywords
- Therapy for diabetic macular edema, Curcumin formulation (DIABEC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIABEC plus intravitreal dexamethazone | Experimental | Combination Product: DIABEC plus intravitreal dexamethazoneIntervention: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 |
| dexamethazone intravitreal injection | No intervention | –Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIABEC plus intravitreal dexamethazoneAlso: Intravitreal dexamethazonePatients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC) | Combination product | DIABEC plus intravitreal dexamethazone |
Primary outcome
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
3 secondary outcomes
Mean difference in BCVA from baseline to 6 months
Time frame: 6 months
Evaluation of safety: incidence of Treatment-Emergent Adverse Events
Time frame: 6 months
Retreatment times
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariacristina Parravano principal investigator
Fondazione G.B. Bietti, IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIABEC plus intravitreal dexamethazone in people with Diabetic Macular Edema, run by Fondazione G.B. Bietti, IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in CRT from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.