UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration in Japanese Patients
Title of the study (Brief title)	Ranibizumab for Exudative Age-Related Macular Degeneration
Region	Japan

Condition
Condition	Exudative Age-Related Macular Degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of ranibizumab for exudative age-related macular degeneration in Japanese with prospective treatment regimen
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	The mean changes of best-corrected visual acuity at month 24 compared with baseline
Key secondary outcomes	The prevalence of eyes with only ranibizumab by PRN (pro re nata)

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ranibizumab ; Monthly (3 times) to PRN regimen
Interventions/Control_2	Ranibizumab ; Monthly (3 times) to Treat and Extend regimen
Interventions/Control_3	Ranibizumab ; Monthly (3 times) to Treat and Extend regimen followed by Aflibercept ; Treat and Extend regimen
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) naive neovascular AMD with older than 50 years and acceptance of this study 2) typical AMD
Key exclusion criteria	1) previous treatment for AMD 2) polypoidal choroidal vasculopathy 3) retinal angiomatous proliferation 4) diabetic maculopathy, retinal vascular occlusion, or idiopathic macular telangiectasia
Target sample size	50

Research contact person
Name of lead principal investigator	Masaaki Saito
Organization	Akita University
Division name	Department of Ophthalmology
Address	44-2 Hasunuma-Hiroomote, Akita city, Akita, Japan
TEL	018-834-1111
Email	masaaki@med.akita-u.ac.jp

Public contact
Name of contact person	Masaaki Saito
Organization	Akita University
Division name	Department of Ophthalmology
Address	44-2 Hasunuma-Hiroomote, Akita city, Akita, Japan
TEL	018-834-1111
Homepage URL
Email	masaaki@med.akita-u.ac.jp

Sponsor
Institute	Akita University Department of Ophthalmology
Institute
Department

Funding Source
Organization	Alcon Pharmaceuticals
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Akita City Hospital
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	秋田大学病院（秋田県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 07 Day
Anticipated trial start date	2017 Year 07 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	2017 Year 06 Month 17 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031853