Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00272

2 Trial Registration Date

2010-11-30

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Heath and Health Services Research Fund, Food and Health Bureau, 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

Ms. Joyce Kung

ii Address

Department of Ophthalmology & Visual Sciences, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

2762 3134

iv Email

joycekung@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Dr. Lai Yuk Yau Timothy

ii Address

Department of Ophthalmology & Visual Sciences, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

2762 3153

iv Email

tyylai@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomized controlled trial of intravitreal bevacizumab monotherapy versus triple therapy with half fluence verteporfin photodynamic therapy and intravitreal bevacizumab and triamcinolone acetonide for the treatment of neovascular age-related macular degeneration

10 Public Title

A randomized controlled trial of intravitreal bevacizumab monotherapy versus triple therapy with half fluence verteporfin photodynamic therapy and intravitreal bevacizumab and triamcinolone acetonide for the treatment of neovascular age-related macular degeneration

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?

2010-01-15

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Age-related macular degeneration

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Photodynamic therapy with verteporfin; intravitreal bevacizumab and intravitreal triamcinolone acetonide

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Triple therapy using photodynamic therapy with verteporfin, intravitreal 1.25mg bevacizumab injection and intravitreal 2mg triamcinolone acetonide injection compared with monotherapy with intravitreal 1.25mg bevacizumab injection. Patients will be assessed monthly for 12 months and treated based on the disease activity.

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

1. Patients aged 55 years or more
2. Neovascular AMD with active leakage involving the fovea on fluorescein angiography (FA) and/or indocyanine green angiography (ICGA);
3. Best-corrected visual acuity (BCVA) with ETDRS letter score of 68 to 4 letters (Snellen equivalent of 20/40 to 20/800) in the affected eye;
4. Patients physically fit to receive intravitreal injection; and
5. Informed consent.
In patients with bilateral presentations, only the eye with more recent of symptoms will be recruited in the study and the fellow eye will be treated according to the patient’s preference.

ii Exclusion Criteria

1. Coexisting ocular pathology other than visually non-significant cataract
2. High myopia with refractive error of -6 dioptres or higher
3. Media opacities which affect fundus examination or OCT measurements;
4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens implantation;
5. Cataract extraction or laser procedure within 6 months of enrolment;
6. Failure to comply with follow up schedule;
7. PDT with verteporfin within 6 months in the study eye;
8. Anti-VEGF therapy including pegaptanib, bevacizumab and ranibizumab within 6 months in the study eye.
9. Previous submacular surgery or external beam radiation therapy;
10. History of fluorescein allergy;
11. History of prophyria;
12. Known sensitivity to verteporfin or bevacizumab;
13. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication);
14. Aphakia with absence of the posterior capsule in the study eye;
15. Active intraocular inflammation in the study eye; and
16. Retinal pigment epithelial tear involving the macula in the study eye.

iii Age Minimum

55

iv Age Maximum

none

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-08-26

21 Target Sample Size

100

22 Recruitment Status

Complete

23 Primary Outcome

The best-corrected visual acuity (BCVA) measured by ETDRS letter score at 12 months

24 Secondary Outcome

1. number of intravitreal bevacizumab injections required during the 12 month period;
2. levels of aqueous angiogenesis-related growth factors including VEGF and PEDF;
3. retinal thickness measured by optical coherent tomography (OCT);
4. proportion of patients with moderate visual loss;
5 proportion of patients with stable or improvement in vision;
6. changes in fluorescein angiography (FA) findings;
7. number of photodynamic therapy during the study period;
8. number of IVTA during the study period; and
9. multifocal electroretinography (mfERG).

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-05-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10001137

28 Date of Registration in Primary Registry

2011-01-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-05-07