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 UMIN000002128
Receipt No. R000002600
Scientific Title Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD)
Date of disclosure of the study information 2009/06/29
Last modified on 2019/01/04

* 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 Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD)
Acronym Conbination therapy for AMD
Scientific Title Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD)
Scientific Title:Acronym Conbination therapy for AMD
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 of anit-VEGF therapy combined with photodynamic therapy in AMD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes visual acuity, fundus examination including FA, IA and optical coherence tomography(OCT).
Key secondary outcomes general examination of ocular findings

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cases with age-related macular degeneration
Key exclusion criteria subjects with systemic risk factors
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Yamashita
Organization Yamagata University Hospital
Division name Department of Ophthalmolgy
Zip code
Address Iidanishi2-2-2, yamagata
TEL 023-628-5374
Email shionhaneda055@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Yamashita
Organization Yamagata University Hospital
Division name Department of Ophthalmolgy
Zip code
Address Iidanishi2-2-2, yamagata
TEL 023-628-5374
Homepage URL
Email shionhaneda055@gmail.com

Sponsor
Institute Yamagata University Hospital
Institute
Department

Funding Source
Organization Yamagata University Hospital
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
2009 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2019 Year 01 Month 04 Day
Date trial data considered complete
2019 Year 01 Month 04 Day
Date analysis concluded
2019 Year 01 Month 04 Day

Other
Other related information Mauclar thickness from baseline significantly changed in combined therapy group compared with single treatment group.

Management information
Registered date
2009 Year 06 Month 27 Day
Last modified on
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.