diabetic macular edema
Conditions
Interventions
Patients with diabetic macular edema receive bi-monthly aflibercept intravitreal injections. When the best-corrected visual acuity worsen more than 0.3 logMAR visual acuity one month after each injec
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Definite retinal thickening due to diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss. Best-corrected logMAR visual acuity in baseline > 0.22. Retinal thickness measured on spectral domain optical coherence tomography > 300 micron in the central subfield.
Exclusion criteria
Exclusion criteria: Anti-VEGF therapy within the prior 3 months. Retinal photocoagulation within the prior 3 months. Steroid therapy within the prior 3 months. Major ocular surgery within the prior 3 months. A myocardial infarction or other cardiac event requiring hospitalization. Cerebrovascular accident, transient ischemic attack, or acute congestive heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in best-corrected visual acuity from baseline to six months or 12 months after the initial injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of improvement or no change or worsening in change of best-corrected visual acuity from baseline to six months or 12 months after the initial injection Change in fluorescin angiography and optical coherence tomography (OCT) | — |
Countries
Japan
Contacts
Public ContactOsamu Sawada
Shiga University of Medical Science Ophthalmology
Outcome results
None listed