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

iRegistration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

N/A

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

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

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13Research 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

15Intervention

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

16Comparative 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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: 1. Documented CSME defined according to ETDRS guidelines. 2. Macular thickening ¡Ù 250£gm 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

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study 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

Recruiting

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.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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

None

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Trial History Detail on 2005-12-06