Ranibizumab Treatment for Age-Related Macular Degeneretion (QUATRO)

June 5, 2014 updated by: Yuji Oshima, Kyushu University

The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients

To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • Japan
    • Fukuoka
      • Maidashi, Higashiku, Fukuoka-city, Fukuoka, Japan, 812-8582
        • Recruiting
        • Department of Ophthalmology, Kyushu University Hospital
        • 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:

  • Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
  • Subjects of either gender age 50 years or older
  • Visual acuity better than 0.05 decimal( 20/400 Snellen)
  • Signed informed consent form

Exclusion Criteria:

  • Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
  • Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
  • Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
  • Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
  • Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
  • The pregnant or lactating woman

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Drug: Intravitreal Lucentis 0.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline change of visual acuity and QOL after ranibizumab treatment
Time Frame: 3 months
Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations
Time Frame: 1year
1year

Other Outcome Measures

Outcome Measure
Time Frame
Baseline change of central retinal thickness by OCT examination.
Time Frame: 3 months, 1 year
3 months, 1 year

Collaborators and Investigators

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

Sponsor

Kyushu University

Collaborators

Novartis
Kurume University
Fukuoka University
University of Occupational and Environmental Health
Clinical Research Support Center Kyush

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 (Anticipated)

April 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-E-09

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.

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