Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD

Neovascular Age-related Macular Degeneration Clinical Trial

— ARTIS  

Official title:

Random, Open-label Multicenter, Phase IV Study Assessing the Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810808
• Other study ID #: 13411950400
• Status: Recruiting
• Phase: Phase 4
• First received: May 3, 2014
• Last updated: November 3, 2016
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xiaodong Sun, M.D.
• Phone: +86-02163240090
• Email: xdsun[@]sjtu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Written informed-consent before any evaluation

• Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV.

• 50 years old and older

• Chinese

• For study eye: screening and baseline BCVA scores both should be between 78 and 23 words (including 78 and 23 words) (approximately equals to 20/30-20/320 sneeleen vision chart units) while tested at 4 meters with ETDRS vision chart.

Exclusion Criteria:

• Have Stroke and myocardial infarction within 3 months before screening

• Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.

• Uncontrolled glaucoma (under treatment [IOP] = 30 mm Hg or depend on researchers) while screening and baseline

• Neovascularization of iris and neovascular glaucoma while screening and baseline

• Any causes led to choroidal neovascularization except Wet AMD (including ICNV,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline

• With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers

• Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening

• Any medication systemic use toxic to lens, retina and optic nerve,including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol

• For study eye:Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib (Macugen®),ranibizumab ,bevacizumab(Avastin®),VEGF-Trap,KH902;b)Anecortave acetate corticosteroids;c)Protein kinase C inhibitors,squalamine,siRNA; d)PDT (Visudyne®)treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy

• Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated within 6 months after baseline

• Intraocular or periocular treatment of corticosteroids within 3 months before baseline

• For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,like Lucentis,Avastin® and KH902 ) within 3 months before baseline

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Procedure:
• 1+PRN
PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.
• 3+PRN
PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.

Drug:
• Ranibizumab
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

Locations

Country	Name	City	State
China	Eye & Ent Hospital of Fudan University	Shanghai
China	Shanghai 10th People's Hospital	Shanghai
China	Shanghai First People's Hospital	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Eye & Ent Hospital of Fudan University, Shanghai 10th People's Hospital, Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Mean number of injections in 12 months	Compare of mean number of injection in 12 months between the two groups to assess the efficacy of 1+PRN of Ranibizumab.	12 months	No
Secondary	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	No