UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012013 |
|---|---|
| Receipt number | 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 08:33:02 |
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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
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
yuji@eye.med.kyushu-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014037
