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Neovascular Age-related Macular DegenerationPhase 4ARTISNCT02810808

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

A Phase 4 study testing 1+PRN, 3+PRN and Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
1+PRN, 3+PRN and Ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
5 sitesChina
Study dates
Dec 2013to Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

Xiaodong Sun, M.D. contact

+86-02163240090 ext. 6822

xdsun@sjtu.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Eye & Ent Hospital of Fudan University

    Shanghai, 200080

    Qing Chang, M.D., +8613916827595, qingchang@yahoo.com

    Recruiting

  • Shanghai 10th People's Hospital

    Shanghai, 200080

    Fang Wang, M.D., +8618917683335, dreyemilwang_122@163.com

    Recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080

    Xiaodong Sun, M.D., +86 21 63240090 ext. 6822, xdsun@sjtu.edu.cn

    Xiaodong Sun, M.D.

    Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, 200080

    Fei Yuan, M.D., +8613816852158, yuan.fei@zs-hospital.sh.cn

    Recruiting

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200080

    Peiquan Zhao, M.D., +8613311620396, zhaopeiquan@126.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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

Being tested
1+PRN, 3+PRN, Ranibizumab
Keywords
Neovascular Age-related Macular Degeneration, Ranibizumab, Pro Re Nata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1+PRNProcedure or surgery

    PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.

  • 3+PRNProcedure or surgery

    PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.

  • RanibizumabDrug

    Also called Lucentis

    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

Study groups in NCT02810808
Study groupRoleWhat they receive
Ranibizumab 0.5 mg 1+PRNExperimentalPRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 11 month treatment period Intervention: Drug: Ranibizumab
Receives: Procedure: 1+PRN; Drug: Ranibizumab
Ranibizumab 0.5 mg 3+PRNActive comparatorPRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization after three Monthly intravitreal injections of the same dose.
Receives: Procedure: 3+PRN; Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (3)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2016 (estimated)
  2. Study startDec 2013
  3. Primary completionSep 2016
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02810808
Sponsor's protocol ID
13411950400
Acronym
ARTIS
Status last verified
Jun 2016
First submitted
3 May 2014
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 10366070

  • 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.

    PubMed 11297486

  • 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.

    PubMed 14711715

  • 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.

    PubMed 12642312

  • 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.

    PubMed 17021318

  • 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.

    PubMed 17021319

  • 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.

    PubMed 19376495

  • 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.

    PubMed 20163368

  • 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.

    PubMed 21526923

  • 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.

    PubMed 31687203

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 1+PRN, 3+PRN and Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaodong Sun, M.D. (+86-02163240090 ext. 6822, xdsun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Snellen BCVA at every visit (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02810808, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.

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