Plaqenil Role in Prevention of Age Related Macular Degene... | NCT01541449

Studies
Plaqenil Role in Prevention of Age Related Macular Degeneration

NCT01541449

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Mar 1, 2012Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Age Related Macular Degeneration

Interventions

Not provided

Countries

Israel

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 2012

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

Jan 2012

Primary Completion Date

Not provided

Completion Date

Apr 2012Estimated

First Submitted Date

Feb 2, 2012

First Submission Date that Met QC Criteria

Feb 29, 2012

First Posted Date

Mar 1, 2012Estimated

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

Feb 29, 2012

Last Update Posted Date

Mar 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth.

Detailed Description

the study is done by comparing to groups RA patients who take plaquenil Vs. group of patients who do not take plaquenil. after measuring the retina thickness we compare the avg. thickness of both groups.

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

No data available

No data is available for this block.

Enrollment

30Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all people who suffer from rheumatoid arthritis (RA) and use plaquenil

Exclusion Criteria:

patients who did not complete follow-up

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Ziv Medical center retina clinic population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Pikkel, M.D	Contact	0508434206		pikel.y@ziv.health.gov.il

Overall Officials

Name	Affiliation	Role
Joseph pikkel, M.D	Ziv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical Center	Recruiting	Safed		13100	Israel

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

Label	Type	Description	Intervention Names
RA patients treated with plaquenil
Patients who do not use plaquenil