Y402H Comlement Factor H Polymorphism and Age-Related Mac... | NCT00533754

Studies
Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population

NCT00533754

Sponsor

Rudolf Foundation Clinic

Status

Unknown status

Last Update Posted

Sep 21, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration

Interventions

drawing blood

Countries

Austria

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

ID	Type	Description	Link
EK 06-076-VK

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Nov 2007Estimated

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 20, 2007

First Posted Date

Sep 21, 2007Estimated

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

Sep 20, 2007

Last Update Posted Date

Sep 21, 2007Estimated

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

The aim of the study is to show a higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals.

Additionaly a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
drawing blood	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals

Secondary Outcomes

Measure	Description	Time Frame
a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

man and women over 18 years old
Filled out informed consentBereitschaft zur Teilnahme
Diagnosis of non-exudative/ exudative age related macular dgeneneration

Exclusion Criteria:

inherited retinal diseases
other aquired retinal/ macular
missing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne Binder, M.D.	Rudoulf Foundation Clinic	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rudoulf foundation Clinic		Vienna	State of Vienna	1030	Austria

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided