UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014056
Receipt No. R000016367
Scientific Title Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Date of disclosure of the study information 2014/06/01
Last modified on 2019/03/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Acronym Treat and exted regimen in exdative age related macular degeneration
Scientific Title Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Scientific Title:Acronym Treat and exted regimen in exdative 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 We evaluate the simplified treat and extend regimen using ranibizumab about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The change of best corrected visual acuity and central retinal thickness (at 12th and 24th months).
Key secondary outcomes 1:A drop-out rate of the third month and the twelfth month
2:The study continuance rate until 24 months

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ranibizumab
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 Subjects were eligible if the following criteria were met.
1) ability to provide written informed consent for this study
2) age>=50years old
3) intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical AMD and PCV)
4) best corrected visual acuity>=0.05
Key exclusion criteria 1) past intravitreal anti-VEGF therapy in the study eye
2) past intravitreal or subtenon injection of steroid therapy in the study eye
3) past vitrectomy therapy in the study eye
4) infection or suspicion of infection in eyes or periocular region
5) severe intraocular inflammation in eyes
6) past allergic reaction for ranibizumab
7) past allergic reaction for fluorescein, indocyanine green or iodine
8) pregnancy (positive pregnancy test) or lactating women
9) other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-174 Edobashi Tsu, Mie, Japan
TEL 059-232-1111
Email ganka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Matsubara
Organization Mie University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-174 Edobashi Tsu, Mie, Japan
TEL 059-232-1111
Homepage URL
Email hmastu@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Department of Ophthalmology
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 11 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 06 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
2014 Year 05 Month 24 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016367

Research Plan
Registered date File name
2019/03/08 研究実施計画書簡易 .doc

Research case data specifications
Registered date File name
2019/03/08 データー仕様書.xlsx

Research case data
Registered date File name
2019/03/08 UMIN登録最終.xlsx


Contact us.