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

Not applicable

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

Miss Joyce Kung

ii Address

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

iii Phone

27623134

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

10 Public Title

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

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?

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 >/= 50% of the area of the total lesion Greatest linear dimension of the entire lesion must not exceed 5400 µm 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

ii Exclusion Criteria

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

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

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

Complete

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

ChiCTR-TRC-05000641

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 2013-09-11