Ranibizumab Treatment for Age-Related Macular Degeneretion | NCT02158624

Studies
Ranibizumab Treatment for Age-Related Macular Degeneretion

NCT02158624

Sponsor

Kyushu University

Status

Unknown status

Last Update Posted

Jun 9, 2014Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Visual Disorder Due to Age-related Macula Degeneration

Interventions

Intravitreal Lucentis 0.5mg

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Apr 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 5, 2014

First Submission Date that Met QC Criteria

Jun 5, 2014

First Posted Date

Jun 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2014

Last Update Posted Date

Jun 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuji Oshima, Assistant professor, Kyushu UniversityPrincipal Investigator

Lead Sponsor

Kyushu UniversityOTHER

Collaborators

Name	Class
University of Occupational and Environmental Health	OTHER
Kurume University	OTHER
Fukuoka University	OTHER
Clinical Research Support Center Kyush

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Ranibizumab	Experimental		Drug: Intravitreal Lucentis 0.5mg

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Lucentis 0.5mg	Drug		Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline change of visual acuity and QOL after ranibizumab treatment	Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.	3 months

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations		1year

Other Outcomes

Measure	Description	Time Frame
Baseline change of central retinal thickness by OCT examination.		3 months, 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
Subjects of either gender age 50 years or older
Visual acuity better than 0.05 decimal( 20/400 Snellen)
Signed informed consent form

Exclusion Criteria:

Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
The pregnant or lactating woman

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tatsuro Ishibashi, MD. PhD	Contact	+81-92-642-5648		ishi@eye.med.kyushu-u.ac.jp
Yuji Oshima, MD. PhD	Contact	+81-92-642-5648		yuji@eye.med.kyushu-u.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Kyushu University Hospital	Recruiting	Maidashi, Higashiku, Fukuoka-city	Fukuoka	812-8582	Japan