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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| dexamethazone intravitreal injection | No Intervention | Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIABEC plus intravitreal dexamethazone | Combination Product | Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Evaluation of safety: incidence of Treatment-Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariacristina Parravano | Fondazione G.B. Bietti, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Humanitas Gavazzeni Bergamo | Bergamo | 24125 | Italy | |||
| Università degli Studi Magna Graecia |
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To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months |
| 6 months |
| Retreatment times | To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times | 6 months |
| Catanzaro |
| 88100 |
| Italy |
| Fondazione G.B.Bietti-IRCCS | Rome | 00198 | Italy |