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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810808
Recruitment Status : Unknown
Verified June 2016 by Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborators:
Eye & ENT Hospital of Fudan University
Shanghai 10th People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Procedure: 1+PRN Procedure: 3+PRN Drug: Ranibizumab Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2013
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab 0.5 mg 1+PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 11 month treatment period Intervention: Drug: Ranibizumab
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.

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
Other Name: Lucentis

Active Comparator: Ranibizumab 0.5 mg 3+PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization after three Monthly intravitreal injections of the same dose.
Procedure: 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
Other Name: Lucentis




Primary Outcome Measures :
  1. Mean Snellen BCVA at every visit [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 12 months ]
    Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of 1+PRN of Ranibizumab.

  2. Mean number of injections in 12 months [ Time Frame: 12 months ]
    Compare of mean number of injection in 12 months between the two groups to assess the efficacy of 1+PRN of Ranibizumab.

  3. mean central macular thickness at every visit by OCT [ Time Frame: 12 months ]
    Compare of mean central macular thickness by OCT at every visit between the two groups to assess the efficacy of 1+PRN of Ranibizumab.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810808


Contacts
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Contact: Xiaodong Sun, M.D. +86-02163240090 ext 6822 xdsun@sjtu.edu.cn

Locations
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China
Eye & Ent Hospital of Fudan University Recruiting
Shanghai, China, 200080
Contact: Qing Chang, M.D.    +8613916827595    qingchang@yahoo.com   
Shanghai 10th People's Hospital Recruiting
Shanghai, China, 200080
Contact: Fang Wang, M.D.    +8618917683335    dreyemilwang_122@163.com   
Shanghai First People's Hospital Recruiting
Shanghai, China, 200080
Contact: Xiaodong Sun, M.D.    +86 21 63240090 ext 6822    xdsun@sjtu.edu.cn   
Principal Investigator: Xiaodong Sun, M.D.         
Shanghai Zhongshan Hospital Recruiting
Shanghai, China, 200080
Contact: Fei Yuan, M.D.    +8613816852158    yuan.fei@zs-hospital.sh.cn   
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200080
Contact: Peiquan Zhao, M.D.    +8613311620396    zhaopeiquan@126.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eye & ENT Hospital of Fudan University
Shanghai 10th People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Xiaodong Sun, M.D. Shanghai General Hospital, Shanghai Jiao Tong University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaodong Sun, Professor and Executive Vicechair of Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02810808    
Other Study ID Numbers: 13411950400
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Neovascular Age-related Macular Degeneration
Ranibizumab
Pro Re Nata
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents