Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00042

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

RGC grant and 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 Randomized, Controlled Trial of Photodynamic Therapy with Verteporfin for Choroidal Neovascularization in Pathologic Myopia in Chinese

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?

2002-04-01

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: aged 18 years or older CNV 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 Best-corrected visual acuity score of at least 34 letters (Snellen equivalent, approximately 20/200 or better) Understand the study and sign the informed consent Exclusion criteria: Other clinical features suggesting that the CNV may be secondary to the other causes other than pathologic myopia (such as large drusen, geographical atrophy, choroioretinal scar) Tear (rip) of the retinal pigment epithelium Any other significant concurrent ocular diseases in study eye disease that has compromised or could compromise vision in the study eye History of the other prior forms of treatment including photodynamic therapy, laser, surgery Active hepatitis or clinically significant liver disease Porphyria or hypersensitivity/allergy to treatment (fluorescein, verteporfin) Pregnancy

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

Single-blind

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

2003-01-01

21 Target Sample Size

72

22 Recruitment Status

Recruiting

23 Primary Outcome

Visual acuity

24 Secondary Outcome

changes in cnv by angiography and optical coherent tomography

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

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