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Trial History Detail on 2011-02-08

CUHK_CCT00189

2009-08-03

Retrospective

Nil

Research Grant Council - General Research Fund 2009-2010

Nil

Nil

Ms. Joyce Kung

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

2762 3134

joycekung@cuhk.edu.hk

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

Dr. Carmen Chan

Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

7388 1054

kmcc2001@hotmail.com

Hong Kong Eye Hospital and the Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

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

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

Hong Kong

Yes

2009-02-10

Diabetic macular edema

Other

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 with type 2 diabetes;
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;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

18 years

None set

Both Male and Female

Interventional

Randomized

Active

Open label

Parallel

2009-04-22

680

Recruiting

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.
4. Patient reported outcomes using quality of life questionnaires

No

2012-07-31

ChiCTR-TRC-09000732

2010-05-04


Yes

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