Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00121

2 Trial Registration Date

2007-07-18

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Department of Ophthalmology and Visual Sciences

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr Timothy Y. Y Lai

ii Address

iii Phone

Telephone 27623159

iv Email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Timothy Y. Y Lai

ii Address

iii Phone

Telephone 27623159

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-09-12

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Neovascular age-related macular degeneration

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

1.25mg intravitreal bevacizumab at monthly interval

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 to 6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

2.5mg intravitreal bevacizumab

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2006-10-01

21 Target Sample Size

50

22 Recruitment Status

Recruiting

23 Primary Outcome

Best-corrected visual acuity at 6 months

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19