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Trial History Detail on 2009-11-19

CUHK_CCT00131

2007-06-01

Prospective

Department of Ophthalmology and Visual Sciences The Chinese University of Hong Kong

Nil

Nil

Prof Dennis SC Lam

email dennislam_cu_res@cuhk.edu.hk

Prof Dennis SC Lam

email dennislam_cu_res@cuhk.edu.hk

The Safety and Efficacy of Combined Subtenon Triamcinolone Acetonide, Intravitreal Bevacizumab and Grid Laser Photocoagulation for Refractory Diabetic Macular Edema - A Pilot Study

Yes

2007-05-04

Refractory diabetic macular edema

Drug

Subtenon triamcinolone, intravitreal bevacizumab injections and macular photocoagulation

2 months

N/A

Inclusion criteria: 1. Aged 18 years or older 2. Recurrent or refractory clinically significant macular edema (CSME), after previous treatment(s), as defined according to the ETDRS 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomogram 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart) 5. Patients physically fit to receive treatment and comply with follow-up schedule 6. Informed consent

Exclusion criteria 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error. 2. Proliferative diabetic retinopathy 3. Media opacities which affect fundus examination or OCT measurements 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment 5. Ocular laser procedure within 4 months 6. History of fluorescein allergy 7. Fellow eye visual acuity worse than 20/400

Non-randomized

Uncontrolled

Open label

Single group

2007-06-10

30

Not Yet Recruiting

1. Best-corrected visual acuity 2. Central foveal thickness as measured by optical coherent tomogram 3. Proportion of patients with a) moderate visual loss or b) stable/ gain in vision

1. Intraocular pressure 2. Changes in fluorescein angiography 3. Adverse events

No

2013-01-14


Yes

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