Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00132

2 Trial Registration Date

2007-07-27

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

Prof Dennis SC Lam

ii Address

iii Phone

iv Email

email dennislam_cu-res@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Prof Dennis SC Lam

ii Address

iii Phone

iv Email

email dennislam_cu-res@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effect of Different Dosages of Intravitreal Bevacizumab (Avastin) in the Treatment of Diabetic Macular Edema: 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

Diabetic Macular Edema

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

1.25mg intravitreal bevacizumab at monthly

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 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: 1. Aged 18 years or older 2. Clinically significant macular edema (CSME) defined according to the ETDRS:- Retinal thickening at or within 500µm of the center of the macula; or - Hard exudates at or within 500µm of the center of the macula associated with adjacent retinal thickening; or - A zone or zones of retinal thickening of one disc area in size and at least part of which is within one disc diameter of the center of fovea 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomography (OCT) 4. Patients with best-corrected visual acuity of better than 1.3 ETDRS logMAR units 5. Patients physically fit to receive intravitreal injection 6. Informed consent

ii Exclusion Criteria

Exclusion Criteria: 1. Ocular diseases other than cataract, CSME and refractive error, which includes: a. Any conditions known to cause macular edema, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularization b. Fibrovascular proliferation with or without tractional retinal detachment; c. Glaucoma and ocular hypertension 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 5. Any laser procedure within 4 months; or cataract extraction or intravitreal triamcinolone injection within 6 months 6. Pregnant patients 7. Failure to comply with follow up schedule 8. Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding 9. "Single eye" patient with fellow eye having best-corrected visual acuity of 20/400 or worse. 10. History of fluorescein allergy 11. Macular ischemia on fluorescein angiography

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

52

22 Recruitment Status

Complete

23 Primary Outcome

Best-corrected visual acuity at 6 months

24 Secondary Outcome

1. Retinal thickness measured by optical coherent tomography (OCT) at each visit 2. Proportion of patients with moderate visual loss at 6 months 3. Proportion of patients with stable or gain in vision at 6 months 4. Intraocular pressure measured by non-contact tonometry (NCT) at each visit 5. Changes in macular function as measured by multifocal electroretinography (mfERG) at each visit 6. Changes in fluorescein angiography at 6 months 7. 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

2013-01-14

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