Trials / Completed
CompletedNCT03598205
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Fondazione G.B. Bietti, IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | DIABEC plus intravitreal dexamethazone | Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC) |
Timeline
- Start date
- 2018-02-05
- Primary completion
- 2018-09-28
- Completion
- 2019-06-10
- First posted
- 2018-07-26
- Last updated
- 2019-07-31
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03598205. Inclusion in this directory is not an endorsement.