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Trial History Detail on 2014-05-07

CUHK_CCT00272

2010-11-30

Retrospective

Nil

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

Nil

Nil

Ms. Joyce Kung

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

2762 3134

joycekung@cuhk.edu.hk

The Chinese University of Hong Kong

Dr. Lai Yuk Yau Timothy

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

2762 3153

tyylai@cuhk.edu.hk

The Chinese University of Hong Kong

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

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

Nil

Hong Kong

Yes

2010-01-15

Age-related macular degeneration

Drug

Photodynamic therapy with verteporfin; intravitreal bevacizumab and intravitreal triamcinolone acetonide

12 months

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.

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.

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.

55

none

Both Male and Female

Interventional

Randomized

Active

Open label

Parallel

2010-08-26

100

Complete

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

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).

No

2014-05-07

ChiCTR-TRC-10001137

2011-01-01


Yes

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