Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00189

2 Trial Registration Date

2009-08-03

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Research Grant Council - General Research Fund 2009-2010

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

Ms. Joyce Kung

ii Address

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

iii Phone

2762 3134

iv Email

joycekung@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Dr. Carmen Chan

ii Address

Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

7388 1054

iv Email

kmcc2001@hotmail.com

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Repeated Bevacizumab and/ or laser for diabetic macular edema

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-02-10

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

Other

Please specify

Drug and Laser photocoagulation

ii Description/ name of Intervention/article

Group 2: Drug: 1.25mg bevacizumab (intravitreal injection)
Group 3: Combined intravitreal 1.25 mg bevacizumab + macular laser photocoagulation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Group 2: Intravitreal bevacizumab injections (1.25mg each) given at 0, 1, 2 months and repeated en b

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Group 1 (Control) :Macular laser photocoagulation performed every 4 months unless the deferral criteria are met.

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. 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.

ii Exclusion Criteria

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

iii Age Minimum

18 years

iv Age Maximum

None set

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

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

2009-04-22

21 Target Sample Size

680

22 Recruitment Status

Recruiting

23 Primary Outcome

Best-corrected visual acuity at 2 years

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-07-31

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000732

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-03-01