Investigates Improvement in Vision Following Switching Fr... | NCT00804934

Studies
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis

NCT00804934

Sponsor

Retina Institute of Hawaii

Status

Completed

Last Update Posted

May 28, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Wet AMD

Interventions

Lucentis

Countries

United States

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

May 2012

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

Feb 2008

Primary Completion Date

Feb 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

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

May 24, 2012

Last Update Posted Date

May 28, 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 purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.

Detailed Description

To determine mean change in visual acuity at 6 and 12 months

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
0			Drug: Lucentis

Name	Type	Description	Arm Group Labels	Other Names
Lucentis	Drug	0.5mg Lucentis every four months	0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change in visual acuity at 6 and 12 months		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age greater then and equal 50 years
Patients with active neovascular AMD
Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
If the patient has bilateral disease and qualifies for the study, both eyes may be included

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:
Pregnancy or lactation
Premenopausal women not using adequate contraception.
Participation in another simultaneous medical investigation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Debra L Shimabukuro, RN	Retina Institute of Hawaii	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Institute of Hawaii		Honolulu	Hawaii	96815	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided