Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00130

2 Trial Registration Date

2007-06-01

iRegistration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

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

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

iv Email

email dennislam_cu_res@cuhk.edu.hk

v Affiliation

vi Country

8Research 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

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

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?

2007-05-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetic macular edema

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Subtenon triamcinolone injection and macular photocoagulation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 months

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

N/A

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. Aged 18 years or older 2. Clinically significant macular edema (CSME) defined according to the ETDRS 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomogram 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart) 5. Patients physically fit to receive treatment and comply with follow-up schedule 6. Informed consent

ii Exclusion Criteria

Exclusion criteria 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error. 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 more than 6 months prior to enrollment 5. History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors. 6. History of fluorescein allergy 7. Fellow eye visual acuity worse than 20/400

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-06-10

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Best-corrected visual acuity 2. Central foveal thickness measured by optical coherent tomogram 3. Proportion of patients with a) moderate visual loss or b) stable/ gain in vision

24 Secondary Outcome

1. Intraocular pressure 2. Changes in fluorescein angiography 3. Adverse events

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

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Trial History Detail on 2009-11-19