Diabetic Macular Edema
Conditions
Keywords
Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant
Brief summary
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is: How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.
Detailed description
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Interventions
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients with type 1 or type 2 diabetes * diabetic macular edema involving the foveal center with CRT \>300 μm measured by OCT * at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF
Exclusion criteria
* uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time * previous IDI * any condition precluding adequate fundus visualization * uncontrolled glaucoma * papillary excavation ≥ 0.7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in central retinal thickness | Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI | Difference among the baseline and the posterior measurements of the CRT with OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity | Prospective: from baseline to 1 month post IDI | Measurement of Best Corrected Visual Acuity before and after IDI |
Countries
Mexico
Outcome results
None listed