UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy and safety of intravitreal injection of ranibizumab every other month for age-related macular degeneration
Title of the study (Brief title)	Ranibizumab every other month for age-related macular degeneration
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety with the change of the frequency of the intravitreal injection of ranibizumab
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Variation on a logarithm of the minimum angle of resolution 12 months after the first intravitreal injection
Key secondary outcomes	The rate of complication 12 months after the first intravitreal injection Variation on a central retinal thickness

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	Duration:12 months Quantity:ranibizumab 0.5mg Number of injection: 6 times a year
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	Patients with active age-related macular degeneration
Key exclusion criteria	severe glaucoma, inflammation disease, diabetic retinopathy
Target sample size	40

Research contact person
Name of lead principal investigator	Masahito Ohji
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	0775482276
Email	ohji@belle.shiga-med.ac.jp

Public contact
Name of contact person	Tomoko Sawada
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	0775482276
Homepage URL
Email	tsawada@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	滋賀医科大学附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 05 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2017 Year 10 Month 20 Day
Date of closure to data entry	2017 Year 10 Month 20 Day
Date trial data considered complete	2017 Year 10 Month 20 Day
Date analysis concluded	2017 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 01 Day
Last modified on	2017 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006731