Back to resultsRanibizumab Treatment for Age-Related Macular Degeneretion (QUATRO)
Primary Purpose
Visual Disorder Due to Age-related Macula Degeneration
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Intravitreal Lucentis 0.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Visual Disorder Due to Age-related Macula Degeneration
Eligibility Criteria
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
Sites / Locations
- Department of Ophthalmology, Kyushu University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
Outcomes
Primary Outcome Measures
Baseline change of visual acuity and QOL after ranibizumab treatment
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.
Secondary Outcome Measures
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations
Full Information
NCT ID
NCT02158624
First Posted
June 5, 2014
Last Updated
June 5, 2014
Sponsor
Kyushu University
Collaborators
University of Occupational and Environmental Health, Kurume University, Fukuoka University, Clinical Research Support Center Kyush, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT02158624
Brief Title
Ranibizumab Treatment for Age-Related Macular Degeneretion
Acronym
QUATRO
Official Title
The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyushu University
Collaborators
University of Occupational and Environmental Health, Kurume University, Fukuoka University, Clinical Research Support Center Kyush, Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Disorder Due to Age-related Macula Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravitreal Lucentis 0.5mg
Primary Outcome Measure Information:
Title
Baseline change of visual acuity and QOL after ranibizumab treatment
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations
Time Frame
1year
Other Pre-specified Outcome Measures:
Title
Baseline change of central retinal thickness by OCT examination.
Time Frame
3 months, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatsuro Ishibashi, MD. PhD
Phone
+81-92-642-5648
Email
ishi@eye.med.kyushu-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Yuji Oshima, MD. PhD
Phone
+81-92-642-5648
Email
yuji@eye.med.kyushu-u.ac.jp
Facility Information:
Facility Name
Department of Ophthalmology, Kyushu University Hospital
City
Maidashi, Higashiku, Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Oshima, MD. PhD
Phone
+81-92-642-5648
Email
yuji@eye.med.kyushu-u.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Ranibizumab Treatment for Age-Related Macular Degeneretion
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