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| Name | Class |
|---|---|
| Eye & ENT Hospital of Fudan University | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Inclusion Criteria: Age ≥ 50 y/o, nAMD patients(including PCV) Best-corrected visual acuity(BCVA) Exclusion Criteria: Previous anti-VEGF treatment within 3 months History of intraocular surgery within 3 months or arrangement of intraocular surgery in the next 6 months from baseline Active or recent intraocular inflammation in the study eye Primary Endpoint: Improvement in BCVA compared to baseline Other: Central Macular Thickness after Treatment,Numbers of Injections
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg 1+PRN | Experimental | PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 11 month treatment period Intervention: Drug: Ranibizumab |
|
| Ranibizumab 0.5 mg 3+PRN | Active Comparator | PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization after three Monthly intravitreal injections of the same dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1+PRN | Procedure | PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Snellen BCVA at every visit | Compare of mean Snellen Best-Corrected-visual-acuity and mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of 1+PRN of Ranibizumab. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of 1+PRN of Ranibizumab. | 12 months |
| Mean number of injections in 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Sun, M.D. | Contact | +86-02163240090 | 6822 | xdsun@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaodong Sun, M.D. | Shanghai General Hospital, Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & Ent Hospital of Fudan University | Recruiting | Shanghai | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10366070 | Background | Friedman DS, Katz J, Bressler NM, Rahmani B, Tielsch JM. Racial differences in the prevalence of age-related macular degeneration: the Baltimore Eye Survey. Ophthalmology. 1999 Jun;106(6):1049-55. doi: 10.1016/S0161-6420(99)90267-1. | |
| 11297486 | Background | Smith W, Assink J, Klein R, Mitchell P, Klaver CC, Klein BE, Hofman A, Jensen S, Wang JJ, de Jong PT. Risk factors for age-related macular degeneration: Pooled findings from three continents. Ophthalmology. 2001 Apr;108(4):697-704. doi: 10.1016/s0161-6420(00)00580-7. |
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| Shanghai Zhongshan Hospital |
| OTHER |
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| 3+PRN | Procedure | PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does. |
|
| Ranibizumab | Drug | Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration |
|
|
Compare of mean number of injection in 12 months between the two groups to assess the efficacy of 1+PRN of Ranibizumab. |
| 12 months |
| mean central macular thickness at every visit by OCT | Compare of mean central macular thickness by OCT at every visit between the two groups to assess the efficacy of 1+PRN of Ranibizumab. | 12 months |
| Shanghai 10th People's Hospital | Recruiting | Shanghai | 200080 | China |
|
| Shanghai First People's Hospital | Recruiting | Shanghai | 200080 | China |
|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | 200080 | China |
|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200080 | China |
|
| 14711715 | Background | Hsu WM, Cheng CY, Liu JH, Tsai SY, Chou P. Prevalence and causes of visual impairment in an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2004 Jan;111(1):62-9. doi: 10.1016/j.ophtha.2003.05.011. |
| 12642312 | Background | Miyazaki M, Nakamura H, Kubo M, Kiyohara Y, Oshima Y, Ishibashi T, Nose Y. Risk factors for age related maculopathy in a Japanese population: the Hisayama study. Br J Ophthalmol. 2003 Apr;87(4):469-72. doi: 10.1136/bjo.87.4.469. |
| 17021318 | Background | Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
| 17021319 | Background | Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655. |
| 19376495 | Background | Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW Jr, Esquiabro M. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol. 2009 Jul;148(1):43-58.e1. doi: 10.1016/j.ajo.2009.01.024. Epub 2009 Apr 18. |
| 20163368 | Background | Tano Y, Ohji M; EXTEND-I Study Group. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta Ophthalmol. 2010 May;88(3):309-16. doi: 10.1111/j.1755-3768.2009.01843.x. Epub 2010 Feb 16. |
| 21526923 | Background | CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28. |
| 31687203 | Derived | Wang F, Yuan Y, Wang L, Ye X, Zhao J, Shen M, Zhang Q, Xu D, Qin G, Zhang W, Yuan F, Chang Q, Zhao P, Wang F, Sun X. One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial. J Ophthalmol. 2019 Oct 10;2019:7530458. doi: 10.1155/2019/7530458. eCollection 2019. |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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