UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients
Title of the study (Brief title)	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	Tatsuro Ishibashi
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Ophthalmology
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	Yuji Oshima
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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