Eye Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All diabetic patients with confirmed DMO – associated visual impairment and the following: Snellen BCVA = 6/9 (equal and worse than 6/9); AND CFT = 250µm on Heidelberg OCT (quality of OCT must be >20)
Exclusion criteria
Exclusion criteria: Patients who have previously received treatment for DMO (anti-VEGF; grid laser; or periocular or intravitreal steroids) Macular oedema from any other causes such as vein occlusions, post cataract surgery and uveitis. Patients with media opacities with a poor view of their fundus or poor quality OCT scans. Patients with macular ischaemia on FA Patients with other causes of poor vision such as corneal opacities, cataracts, media opacities, optic nerve dysfunction, retinal detachments and other macular/retinal pathologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority margin 5 ETDRS letters of the number of letters improved from baseline to the 1 year and 2 year visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Central foveal thickness difference between the 2 groups | — |
Countries
South Africa
Contacts
Coinvestigator