Macular Edema
Conditions
Interventions
This is a phase 1-2 clinical trial, with only 1 arm with 12 diabetic volunteers with macular edema. It will be injected i 0.04 mL (0.08 mg) of dexamethasone disodium phosphate (2 mg/mL) in one eye. Th
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) age 18 years or older; (2) diagnosis of diabetes mellitus for at least 5 years; (3) presence of refractory diabetic macular edema defined as central macular thickness (diabetic macular edema [DME]) >300 µm caused by intraretinal or subretinal fluid and a <10% reduction in DME from baseline 1 month after at least three monthly intravitreal anti-VEGF (bevacizumab, ranibizumab, or aflibercept) injections, as measured by spectral-domain optical coherence tomography (SD-OCT); (4) best-corrected visual acuity (BCVA) between 1.3 (20/400) and 0.2 (20/32) LogMAR; and (5) history of uncomplicated ipsilateral cataract surgery with intraocular lens implantation; (6) both genders
Exclusion criteria
Exclusion criteria: (1) any diabetic macular edema (DME) treatment in the last 4 months; (2) panretinal photocoagulation (PRP) in the last 6 months; (3) any ophthalmic surgery performed in the last 4 months; (4) history of pars plana vitrectomy (PPV); (5) history of open-angle glaucoma or corticosteroid-induced elevated intraocular pressure requiring antiglaucoma or antihypertensive ocular treatment; (6) intraocular pressure >= 21 mmHg; (7) history of allergy to any product used in the procedure; (8) presence of tractional retinal detachment affecting the fovea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be change in central macular thickness (CMT) 3 days after intravitreal injection of dexamethasone disodium phosphate 2 mg/mL. Patients who have CMT >300 µm caused by intraretinal or subretinal fluid and/or a reduction of less than 10% in CMT from baseline 3 days after injection will be considered refractory (nonresponders) to dexamethasone disodium phosphate. | — |
Secondary
| Measure | Time frame |
|---|---|
| central macular thickness, at least on day 120, after intravitreal injection of dexamethasone disodium phosphate 2 mg/mL;best corrected visual acuity, at least on day 120, after intravitreal injection of dexamethasone disodium phosphate 2 mg/mL;tonometry, at least on day 120, after intravitreal injection of dexamethasone disodium phosphate 2 mg/mL | — |
Countries
Brazil
Contacts
Public ContactRodrigo Lira
Universidade Federal de Pernambuco
Outcome results
None listed