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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012013
Receipt No. R000014037
Scientific Title The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients
Date of disclosure of the study information 2013/11/01
Last modified on 2016/12/22

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Basic information
Public title The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients
Acronym QUATRO Study
Scientific Title The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients
Scientific Title:Acronym QUATRO Study
Region
Japan

Condition
Condition Age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship of the effect between visual acuity improvement and QOL improvement before and after ranibizumab treatment. Intravitreous ranibizumab injection is performed consecutive 3 times every one month in patients with age-related macular degeneration, and best-corrected visual acuity and VFQ-25 are measured 3 months later.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Baseline change of best-corrected visual acuity (LogMAR) and QOL (VFQ-25) 3 months after ranibizumab administration.
Key secondary outcomes 1) Baseline change of best-corrected visual acuity (LogMAR) just before and 12 months after ranibizumab administration.
2) Baseline change of QOL (VFQ-25) just before and 12 months after ranibizumab administration.
3) Baseline change of central retinal thickness by OCT examination just before, 3 months and 12 months after ranibizumab administration.
4) Patient rate of exudative change (subretinal fluid, retinal edema and serous retinal pigment epithelial detachment) just before, 3 months and 12 months after ranibizumab administration.
5) Baseline change of greatest linear dimension just before, 3 months and 12 months after ranibizumab administration.
6) Baseline change of patient satisfaction questionnaire just before, 3 months and 12 months after ranibizumab administration.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ranibizumab (genetical recombination): Lucentis is 0.5 mg given monthly as a single intravitreal injection. This
corresponds to an injection volume of 0.05 ml.Treatment is given consecutive 3 times every one month as the induction period. In the later maintenance period, dose intervals are appropriately controlled by the patient symptoms, but the dose intervals are left more than 1 month.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with age-related macular degeneration accompanied by exudative change by FA, ICGA or OCT examination.
2) Best-corrected visual acuity (decimal point visual acuity) of subject eye is more than 0.05.
3) Both genders at more than 50 years old.
4) Patients providing written informed consent.
Key exclusion criteria 1) Patients whose lesion site evaluated by FA examination is more than 12 optic disc areas (1 optic disc area is 30.5mm2, a lesion including a bleeding, scar and neo-vascularization) in subject eye.
2) Patient with a scar or fibrosis in the range more than 50% of all lesions in subject eye.
3) Patients with a history of retinal pigment epithelium tear or rupture in subject eye.
4) Patients with a history of more than stage 3 macular hole in subject eye.
5) Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye.
6) Patient with a history of intraocular surgical operation (including cataract) within 3 months in subject eye.
7) Patient with a history of surgical operation such as vitrectomy and submacular surgery in subject eye.
8) Patients with intraocular, extraocular and periocular inflammation or infectious in either eye.
9) Patients with a history of uveitis in either eye.
10) Patients with serious allergic history to such as fluoresceine, indocyanine green, iodo.
11) Women who have pregnancy, possibility of the pregnancy or are nursing.
12) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuro Ishibashi
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Ophthalmology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL 092-642-5648
Email ishi@eye.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Oshima
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Ophthalmology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL 092-642-5648
Homepage URL
Email yuji@eye.med.kyushu-u.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Novartis Pharma K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院(福岡県)、福岡大学病院(福岡県)、久留米大学病院(福岡県)、産業医科大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 10 Day
Last modified on
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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