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Trial History Detail on 2016-06-22

CUHK_CCT00458

2015-06-17

Prospective

N/A

Novartis Pharmaceuticals (HK) Ltd.

Novartis Pharmaceuticals (HK) Ltd.

N/A

Not Applicable

Miss Mak Hoi Ching Haley

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

3943 5833

haleymak@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Dr Mårten BRELÉN

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

3943 5846

marten.brelen@cuhk.edu.hk

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

Hong Kong

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

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

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

Combined IVTA and ranibizumab vs ranibizumab monotherapy for AMD

Hong Kong

Yes

2015-05-29

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KE-15-0053/FR-2

triamcinolone acetonide, ranibizumab, neovascular age-related macular degeneration

Drug

ranibizumab 4mg, triamcinolone acetondie 0.5mg

injection

ranibizumab 4mg, triamcinolone acetondie 0.5mg

Seven Months

monthly

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.

Injection

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.

3 months

Monthly

• 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

• 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

50

999

Both Male and Female

Interventional

Randomized

Prospective and Randomized controlled trial

Active

Single-blind

Trial subjects

Parallel

Other

NA

2015-06-30

50

Not Yet Recruiting

Incidence and severity of ocular adverse events and visual acuity

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.

No

2018-06-28

ChiCTR-ICR-15006619 

2015-06-17

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