Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00054

2 Trial Registration Date

2005-09-23

i Registration Status

Prospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

N/A

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

Miss Joyce Kung

ii Address

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

iii Phone

27623134

iv Email

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

Prof. Dennis SC Lam

ii Address

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

iii Phone

27623134

iv Email

email dennislam_cu_res@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

10 Public Title

A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

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?

2005-08-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Grid laser photocoagulation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

1. Posterior subtenon triamcinolone 40mg injection 2. Combined 40mg subtenon TA injection and grid laser

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. Documented CSME defined according to ETDRS guidelines. 2. Macular thickening ≥ 250µm in the foveal center measured on ocular coherent tomography (OCT). 3. Patients physically fit ot receive laser photocoagulation or intravitreal injection. 4. Age of at least 18 years. 5. Informed consent

ii Exclusion Criteria

Exclusion criteria:
1.Macular edema secondary to other causes, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularisation
2.≥ 1 disc diameter of capillary closure at the macula on fluorescein angiography
3.Signs of vitreomacular traction on either biomicroscopy or OCT examination
4.Proliferative diabetic retinopathy requiring immediate treatment
5.History of glaucoma or ocular hypertension
6.Chronic renal failure maintained on renal dialysis
7.Previous intraocular surgery (including previous vitrectomy or trabeculectomy) except uncomplicated cataract extraction and posterior intraocular lens insertion;
8.Any cataract extraction or laser procedure within 3 months
9.Media opacities (including significant cataract which requires cataract removal to improve visual acuity) which affect fundus examination or OCT measurements
10.Fellow eye of visual acuity ≥1.7 ETDRS logMAR units
11.Failure to comply with follow up schedule

iii Age Minimum

18

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

2005-10-01

21 Target Sample Size

90

22 Recruitment Status

Complete

23 Primary Outcome

Best-corrected visual acuity (ETDRS chart)

24 Secondary Outcome

1. Macular eduma measured by optical coherent tomogram (OCT) - a non-contact and non-invasive investigation to assess the degree of macular edema. 2. Side effects including a) Intraocular pressure measured by non contact tonometer(NCT); b) Degree of cataract assessed clinically according to the Lens Opacity Classification System (LOCS) III.

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

ChiCTR-TRC-09000666

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 2012-04-17