Trial History Detail on 2009-08-03





Research Grant Council - General Research Fund 2009-2010



Ms. Joyce Kung

Department of Ophthalmology & Visual Sciences, CUHK, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

Tel: 2762 3134; Email:

Dr. Carmen Chan

Hong Kong Eye Hospital, 147K Argyle Street, Kowloon


A randomized controlled trial to compare the efficacy and safety of 1) macular laser vs. 2) repeated intravitreal bevacizumab vs. 3) combined repeated intravitreal bevacizumab with macular laser for diabetic macular edema

Repeated Bevacizumab and/ or laser for diabetic macular edema



Diabetic macular edema


Drug and Laser photocoagulation

Group 2: Drug: 1.25mg bevacizumab (intravitreal injection)
Group 3: Combined intravitreal 1.25 mg bevacizumab + macular laser photocoagulation

Group 2: Intravitreal bevacizumab injections (1.25mg each) given at 0, 1, 2 months and repeated en b

Group 1 (Control) :Macular laser photocoagulation performed every 4 months unless the deferral criteria are met.

Inclusion criteria
1. Age of at least 18 years;
2. Definite retinal thickening due to diffuse DME based on clinical examination with central foveal thickness of at least 250µm 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
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; Chronic renal failure requiring dialysis of renal transplant; Blood pressure >180/110mmHg
7. Allergy to bevacizumab or sodium fluorescein



Open label





Best-corrected visual acuity at 2 years

1. Macular edema reduction (on optical coherent tomography) at 2 years
2. Side effects profile at 2 years
3. Measure vascular endothelial growth factor and pigment epithelium derived factor in aqueous, and correlate this to severity of DME and response to treatment at Baseline, 1 year and 2 year.




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