diabetic macular edema
Conditions
Interventions
Three groups:Group 1 (Control) :Macular laser photocoagulation performed every 4 months unless the deferral criteria are met. Group 2: Intravitreal bevacizumab injections (1.25mg each) given at 0, 1,
and repeated en bloc every 4 months unless the deferral criteria are met..
Sponsors
Nil
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age of at least 18 years with type 2 diabetes; 2. Definite retinal thickening due to diffuse DME based on clinical examination with central foveal thickness of at least 250 involving the fovea, as documented on OCT; 3. Patients with best-corrected visual acuity of between 20/40 and 20/800 (0.24- 1.7 ETDRS logMar units); 4. Patients physically fit to receive laser photocoagulation or intravitreal injections; 5. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error, which includes: any conditions known to cause macular edema, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularisation; fibrovascular proliferation with or without tractional retinal detachment; glaucoma and ocular hypertension etc; 2. Foveal atrophy and hard exudates involving fixation; macular ischemia on fluorescein angiography; proliferative diabetic retinopathy requiring treatment; media opacities which affect fundus examination or OCT measurements; 3. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion; Cataract extraction within 6 months or laser procedure (including panretinal photocoagulation, macular laser, Yag capsulotomy) within 4 months; 4. History of intravitreal/ periocular corticosteroid or anti-VEGF injections within 6 months; 5. Fellow eye with visual acuity worse than 20/400; 6. Systemic exclusion criteria: history of thromboembolic disease; pregnancy; lactating women, Chronic renal failure requiring dialysis of renal transplant; Blood pressure 180/110mmHg; 7. Women of child-bearing potential unless they are using two effective birth control methods and men who do not agree to use contraception, during the duration of the study until 16 weeks after the last study treatment; 8. Allergy to bevacizumab or sodium fluorescein.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity at 2 years; | — |
Contacts
Public ContactDr. Carmen Chan
Outcome results
None listed