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Trial History Detail on 2009-11-19

CUHK_CCT00121

2007-07-18

Retrospective

Department of Ophthalmology and Visual Sciences

Nil

Nil

Dr Timothy Y. Y Lai

Telephone 27623159

Dr Timothy Y. Y Lai

Telephone 27623159

Effects of Different Dosages of intravitreal Bevacizumab (Avastin) for Neovascular Age-related Macular Degeneration: A Randomized Controlled Trial

Yes

2006-09-12

Neovascular age-related macular degeneration

Drug

1.25mg intravitreal bevacizumab at monthly interval

3 to 6 months

2.5mg intravitreal bevacizumab

Inclusion criteria: i. Aged 50 years or older ii. Subfoveal CNV within the foveal avascular zone due to AMD iii. Patients with best-corrected visual acuity of better than 1.3 ETDRS logMAR units iv. Patients physically fit to receive intravitreal injection v. Informed consent

Exclusion criteria: i. Coexisting ocular pathology other than cataract ii. Media opacities which affect fundus examination or OCT measurements iii. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens implantation iv. Any cataract extraction or laser procedure within 6 months of enrolment v. Pregnant patients vi. Failure to comply with follow up schedule vii. "Single" eye patients with fellow eye of 20/400 or worse viii. Verteporfin (Visudyne, Novartis AG, Basel, Switzerland) therapy within 1 month of enrolment in the study eye or 7 days in the fellow eye ix. Previous anti-VEGF therapy including pegaptanib, bevacizumab and ranibizumab. x. Previous submacular surgery or external beam radiation therapy xi. History of fluorescein allergy

Randomized

Active

Double-blind

Parallel

2006-10-01

50

Recruiting

Best-corrected visual acuity at 6 months

i. Retinal thickness measured by optical coherent tomography (OCT) at each visit ii. Proportion of patients with moderate visual loss at 6 months iii. Proportion of patients with stable or gain in vision at 6 months iv. Intraocular pressure measured by non-contact tonometry (NCT) at each visit v. Changes in macular function as measured by multifocal electroretinography (mfERG) at each visit vi. Changes in fluorescein angiography at 6 months vii. Change in levels of aqueous VEGF, PEDF and other growth factors / cytokines during the study period

No

2009-11-24


Yes

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