Macular Edema
Conditions
Interventions
The sample will consist of one eye of 48 diabetic volunteers with DME divided into 4 groups of 12 individuals randomized through a 1:1:1:1 sequential allocation. In the first group the anti-VEGF ranib
data will be computer generated and stored in a locked cabinet until the end of the study period. Volunteers and those responsible for data collection will be masked. Calculations based on the effect
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age equal to or greater than 18 years; both genders; diagnosis of diabetes; presence of clinically significant diabetic macular edema in at least one eye according to the ETDRS (Early Treatment Diabetic Retinopathy Study) guidelines; Best Corrected Visual Acuity between 20/400 and 20/40; Central Macular Thickness >= 300 µm, measured by Spectral Domain Optical Coherence Tomography
Exclusion criteria
Exclusion criteria: Any diabetic macular edema treatment in the last 4 months; Panretinal photocoagulation in the last 4 months; any eye surgery performed in the last 4 months; history of Pars Plana Vitrectomy; hx of open-angle glaucoma or corticosteroid-induced elevated intraocular pressure requiring ocular antiglaucoma or antihypertensive treatment; intraocular pressure >= 21 mmHg; history of allergy to any product used in the procedure; presence of tractional retinal detachment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the corrected visual acuity of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with a 4 mg/mL dexamethasone solution 90 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects;To evaluate the macular thickness, through optical coherence tomography, of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with a 4 mg/mL dexamethasone solution 90 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the corrected visual acuity of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with dexamethasone 4 mg/mL solution one, three, seven, 30 and 60 days after the first intravitreal injection. . Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects;To evaluate the macular thickness, through optical coherence tomography, of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with a 4 mg/mL dexamethasone solution one, three, seven, 30 and 60 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects;To evaluate the intraocular pressure, through applanation tonometry, of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with dexamethasone 4 mg/mL solution on one, three, seven, 30, 60 and 90 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to have a similar outcome to untreated subjects | — |
Countries
Brazil
Contacts
Public ContactRodrigo Lira
Universidade Federal de Pernambuco
Outcome results
None listed