Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
NCT ID: NCT03598205
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2018-02-05
2019-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
NCT02121262
Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:
NCT05847088
Anti-inflammatory Effect of Curcumin, Homotaurine, Vitamin D3 on Human Vitreous in Patients With Diabetic Retinopathy
NCT04378972
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
NCT05271539
Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density
NCT03361709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
DIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
dexamethazone intravitreal injection
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione G.B. Bietti, IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mariacristina Parravano
MD , Head RETINA UNIT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mariacristina Parravano
Role: PRINCIPAL_INVESTIGATOR
Fondazione G.B. Bietti, IRCCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Università Humanitas Gavazzeni Bergamo
Bergamo, , Italy
Università degli Studi Magna Graecia
Catanzaro, , Italy
Fondazione G.B.Bietti-IRCCS
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FGBBietti
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.