Patient with center-
Conditions
Interventions
receive intravitreous bevacizumab injection every 4 weeks for 3 times,receive intravitreous aflibercept injection every 4 weeks for 3 times
Experimental Drug,Active Comparator Drug
bevacizumab,aflibercept
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: - Patient with center-involved DME with suboptimal response to 3 monthly initial bevacizumab injections (defined as persistent DME in central fovea, intraretinal cystoid space or subretinal fluid persisted, with central subfield thickness ≥305 microns in women and ≥320 microns in men by Heidelberg Spectralis OCT after 3 consecutive injection of bevacizumab) - Age > 18 years old - Visual acuity 6/7.5 – 6/240 (20/25 – 20/800) - No history of prior intravitreal injections or laser to treat macular edema
Exclusion criteria
Exclusion criteria: - Patients with other disorders affecting macular thickness such as retinal vein occlusion, vitreomacular traction, epiretinal membrane, macular hole, choroidal neovascularization and medication known to cause macular edema - Patients with active proliferative diabetic retinopathy and neovascular glaucoma - Patients with ocular media opacity that preclude OCT imaging - Patients who cannot comply to the 3 monthly follow-up visits - Patients with recent onset of thromboembolic events such as stroke and myocardial infarction within 6 months - Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity (VA) gain in non-switching therapy with early-switching to aflibercept therapy in DME every 4 weeks and 1 month after last injection unpaired T-test | — |
Secondary
| Measure | Time frame |
|---|---|
| Central subfield thickness(CST), changes in VA and CST between the two groups, the predicting factor every 4 weeks and 1 month after last injection unpaired T-test,Categorical data-individual counts and proportions | — |
Countries
Thailand
Contacts
Public ContactSomanus Thoongsuwan
Department of ophthalmology, Siriraj hospital
Outcome results
None listed