Response to Ranibizumab in Polypoidal Choroidal Vasculopa... | NCT01271426

Studies
Response to Ranibizumab in Polypoidal Choroidal Vasculopathy (PCV)and SNPs

NCT01271426

Sponsor

Nihon University

Status

Completed

Last Update Posted

Jan 6, 2011Estimated

Enrollment

74Actual

Phase

Not provided

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Not provided

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 5, 2011

First Submission Date that Met QC Criteria

Jan 5, 2011

First Posted Date

Jan 6, 2011Estimated

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

Jan 5, 2011

Last Update Posted Date

Jan 6, 2011Estimated

Description Module

Brief Summary

To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

74Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab		a month after injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Polypoidal choroidal vasculopathy
must have injection of Ranibizumab

Exclusion Criteria:

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

outpatients in hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surugadai Nihon university hospital		1-8-13 Kandasurugadai Chiyoda-ku	Tokyo	101-8309	Japan

Condition Browse Module

MeSH Terms

ID	Term
D000092342	Polypoidal Choroidal Vasculopathy

Ancestor Terms

ID	Term
D020256	Choroidal Neovascularization
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided