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 UMIN000008040
Receipt No. R000009469
Scientific Title A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Date of disclosure of the study information 2012/05/29
Last modified on 2014/12/01

* 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 A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Acronym A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Scientific Title A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Scientific Title:Acronym A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of S-646240 when administered subcutaneously at a dose of 2mg to patients with AMD accompanied by CNV.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Safety: The incidence of adverse event and adverse drug reaction.
Efficacy: Change in best-corrected visual acuity (BCVA) scores in the study eye, using ETDRS chart.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Patients will receive 2 mg (2 mL) of S-646240 subcutaneously in the cervical region or axilla every week from the initiation of study treatment to Week 4 and every two weeks from Week 4 to Week 22.
Interventions/Control_2 Patients will receive 2 mg (2 mL) of S-646240 subcutaneously in the cervical region or axilla every two weeks from the initiation of study treatment to Week 22.
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients in whom active lesion of new-onset CNV in central retinal subfovea of the study eye which cause AMD was found by fluorescein angiography and indocyanine green angiography. (The study eye should be one eye or another.)
(2) Patients whose BCVA score in the study eye, using ETDRS chart, is between 20/25 and 20/200 (between 80 and 35 of letter score).
Key exclusion criteria (1) Patients who have CNV due to other causes than age.
(2) Patients who have previous or present retinal vessel disease other than AMD.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuko Sawada
Organization Shionogi & Co., Ltd.
Division name Global Development
Zip code
Address 12-4, Sagisu 5-chome, Fukushima-ku, Osaka 553-0002, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shionogi & Co., Ltd.
Division name Corporate Communications Department
Zip code
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
Homepage URL
Email

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 05 Month 29 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
2012 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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
2012 Year 05 Month 28 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.