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

November 3, 2016 updated by: Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaodong Sun, M.D.
  • Phone Number: 6822 +86-02163240090
  • Email: xdsun@sjtu.edu.cn

Study Locations

  • China
      • Shanghai, China, 200080
        • Recruiting
        • Eye & ENT Hospital of Fudan University
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiaodong Sun, M.D.
      • Shanghai, China, 200080
      • Shanghai, China, 200080
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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 Names:
  • Lucentis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital
Shanghai 10th People's Hospital
Eye & ENT Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xiaodong Sun, M.D., Shanghai General Hospital, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 3, 2014

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13411950400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neovascular Age-related Macular Degeneration

Clinical Trials on 1+PRN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe