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

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

CHAN Wai Man

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

vi Country

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

i Name

CHAN Wai Man

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-05-01

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 d 20/200 Fluorescein angiographic patterns of either Leakage area either in the subfoveal or juxtafoveal area Area of CNV d 50% of the area of the total lesion Greatest linear dimension of the entire lesion must not exceed 5400 £gm 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

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

Recruiting

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

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 2005-09-08