Diabetic Macular Edema
Conditions
Keywords
Therapy for diabetic macular edema, Curcumin formulation (DIABEC)
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.
Interventions
COMBINATION_PRODUCTDIABEC plus intravitreal dexamethazone
Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Sponsors
Fondazione G.B. Bietti, IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in CRT from baseline to 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in BCVA from baseline to 6 months | 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 | 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 | 6 months | To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times |
Countries
Italy
Outcome results
None listed