Diabetic macular edema Diabetes mellitus Diabetic macular edema Ophthalmic complications of diabetes mellitus Ziv-aflibercept Bevacizumab intravitreal injection anti-vascular endothelial growth factors
Conditions
Interventions
3 monthly intravitreal Ziv-aflibercept injections for treatment of refractory diabetic macular edema and then pro re nata regimen.
Experimental Drug
Ziv-aflibercept
Sponsors
Faculty of Medicine, Khon Kaen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with diabetic macular edema with history of intravitreal Bevacizumab injection at least 3 injections within the past 4 months and are refractory to the treatment 2. During the last 2 intravitreal Bevacizumab injection, the decrease in central subfield thickness is less than 10% from the baseline 3. Central subfield thickness is greater than 300 micrometer at the beginning of the study 4. The glycosylated hemoglobin level in plasma is less than 12%
Exclusion criteria
Exclusion criteria: 1. One-eyed patient 2. Active Ocular infection (including endophthalmitis, infectious conjunctivitis, blepharitis, etc.) 3. Ophthalmic conditions which affect the patients' visual acuity or makes fundus photography impossible. (for example, corneal scar, moderate to severe cataract, vitreous haemorrhage, massive retinal haemorrhage) 4. Patients with history of intravitreal anti-VEGF injection other than Bevacizumab. 5. Patients with history of intravitreal steroid injection in the past 6 months 6. Patients with history of vitreoretinal surgery 7. Patients with history of ophthalmic laser procedure in the past 6 months 8. Severe hypertension (defined as systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg) 9. Renal disease requiring renal replacement therapy or kidney transplant 10. History of ischemic heart disease 11. History of stroke 12. Pregnant women, lactating women, or women with intended pregnancy in the next 6 months 13. Patients who are unable to visit monthly for 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity 6 months LogMAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Central subfield thickness 6 months Optical Coherence Tomography,complications 6 months observation | — |
Countries
Thailand
Contacts
Public ContactTrakanta Wannapanich
Srinagarind hospital, Faculty of medicine, Khon Kaen University
Outcome results
None listed