Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00458

2 Trial Registration Date

2015-06-17

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Novartis Pharmaceuticals (HK) Ltd.

5 Primary Sponsor

Novartis Pharmaceuticals (HK) Ltd.

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Miss Mak Hoi Ching Haley

ii Address

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

iii Phone

3943 5833

iv Email

haleymak@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Dr Mårten BRELÉN

ii Address

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

iii Phone

3943 5846

iv Email

marten.brelen@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prospective study of safety and efficacy of combination therapy using intravitreal triamcinolone acetonide and ranibizumab versus ranibizumab monotherapy for neovascular age-related macular degeneration

10 Public Title

Prospective study of safety and efficacy of combination therapy using intravitreal triamcinolone acetonide and ranibizumab versus ranibizumab monotherapy for neovascular age-related macular degeneration

i Public Title in Chinese 研究名稱

比效玻璃體注射類固醇(triamcinolone acetonide)及抗血管內皮生長因子藥物(ranibizumab)聯合療法和單一注射抗血管內皮生長因子藥物(ranibizumab)治療新生血管老年性黃斑病變之療效及安全性的前膽性研究

11 Short Title (Optional)

Combined IVTA and ranibizumab vs ranibizumab monotherapy for AMD

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?

2015-05-29

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-15-0053/FR-2

14 Medical Condition Being Studied

triamcinolone acetonide, ranibizumab, neovascular age-related macular degeneration

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

ranibizumab 4mg, triamcinolone acetondie 0.5mg

iii Dosage form of the intervention

injection

iv Dosage of the intervention

ranibizumab 4mg, triamcinolone acetondie 0.5mg

v Duration of the intervention

Seven Months

vi Frequency of the intervention

monthly

16 Comparative Treatments

i Description/ name of comparative treatments

Group A (combination therapy) received treatments comprised of intravitreal triamcinolone (novartis) 4mg in 0.1 mL followed by intravitreal ranibizumab (novartis) 0.5 mg in 0.05 mL. Group B (monotherapy) receive only intravitreal ranibizumab 0.5 mg in 0.05 mL plus Sham.

ii Dosage form of the comparative treatments

Injection

iii Dosage of the comparative treatments

Group A (combination therapy) received treatments comprised of intravitreal triamcinolone (novartis) 4mg in 0.1 mL followed by intravitreal ranibizumab (novartis) 0.5 mg in 0.05 mL. Group B (monotherapy) receive only intravitreal ranibizumab 0.5 mg in 0.05 mL plus Sham.

iv Duration of the comparative treatments

3 months

v Frequency of the comparative treatments

Monthly

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• Patients with active subfoveal CNV of all types (including predominantly classic, minimally classic, occult, and retinal angiomatous proliferation) secondary to AMD;
• Age beyond 50 years old;
• Only one eye are suffering from CNV;
• Best-corrected visual acuity (BCVA) between 20/32 and 20/320 measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) charts;
• Lesions do not exceed 12 disk areas;
• No more than 50% of the lesions could be occupied by subretinal hemorrhage;
• Pseudophakic eyes
• Patients can give consent

ii Exclusion Criteria

• Eyes with subfoveal fibrosis or atrophy, retinal pigment epithelial tear involving the macula, or subretinal hemorrhage involving the center of the fovea (>50% of the total CNV area);
• Eyes have been treated for AMD with intraocular anti-VEGF therapy or are previous treatment with verteporfin photodynamic therapy or laser photocoagulation within the past 3 months;
• Intraocular surgery within the past 2 months or likely to be performed during the study period;
• Documented diabetic retinopathy, uncontrolled glaucoma, and CNV not related to AMD;
• History or presence of intraocular inflammation or infection;
• History of glaucoma and on more than one topical medication;
• History of glaucoma filtering surgery in the study eye;
• Family history of glaucoma

iii Age Minimum

50

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective and Randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-06-30

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Incidence and severity of ocular adverse events and visual acuity

24 Secondary Outcome

Total number of treatments required, change in central macular thickness (CMT), changes in aqueous concentrations of specific angiogenic and inflammatory cytokines, change in the size of choroidal neovascular membrane in fluorescein angiography and adverse events including retinal pigment epithelial tear, submacular hemorrhage, elevation of intraocular pressure, and endophthalmitis.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-06-28

27 Primary Registry and Trial Identifying Number

ChiCTR-ICR-15006619

28 Date of Registration in Primary Registry

2015-06-17

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Trial History Detail on 2016-06-22