Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00041

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

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

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

Dr. Timothy Y.Y. Lai

ii Address

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

iii Phone

27623134

iv Email

eyeclinic@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 study on the safety and effectiveness of photodynamic therapy with verteporfin in treating chronic focal or diffuse idiopathic central serous chorioretinopathy

10 Public Title

A study on the safety and effectiveness of photodynamic therapy with verteporfin in treating chronic focal or diffuse idiopathic central serous chorioretinopathy

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?

2003-05-19

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

photodynamic therapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

observation

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: Be aged 18 years or older VA with Snellen equivalent </= 20/30 but >/= 20/200 Fluorescein angiographic patterns of either Leakage area either in the subfoveal or juxtafoveal area Area of CNV >/= 50% of the area of the total lesion Greatest linear dimension of the entire lesion must not exceed 5400 µm

ii Exclusion Criteria

Exclusion criteria: on exogenous corticosteroid systemic diseases such as Cushing's disease or renal diseases of glomerulonephritis pregnancy visual acuity worse than 20/200 in the affected eye myopia </= -6.00 diopters or other maculopathy tear (rip) of the retinal pigment epithelium a history of laser photocoagulation ocular surgery in the recent 3 months any contraindication for the verteporfin infusion or fluorescein injection

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

Placebo

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

2005-08-31

21 Target Sample Size

20

22 Recruitment Status

Complete

23 Primary Outcome

Visual acuity

24 Secondary Outcome

duration of subretinal fluid

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-16

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000640

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 2011-02-08