Study Evaluating Genotypes Using Lucentis | NCT00474695

Studies
Study Evaluating Genotypes Using Lucentis

NCT00474695

Sponsor

University of Utah

Status

Terminated

Last Update Posted

Feb 11, 2015Estimated

Enrollment

65Actual

Phase

Not provided

Conditions

Age-Related Maculopathy

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

ID	Type	Description	Link
SEAGUL

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IND holder relocated from the University of Utah

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

May 15, 2007

First Submission Date that Met QC Criteria

May 16, 2007

First Posted Date

May 17, 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

Feb 10, 2015

Last Update Posted Date

Feb 11, 2015Estimated

Name	Class
Genentech, Inc.	INDUSTRY

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 purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Detailed Description

Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Active approved treatment	Drug: Lucentis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lucentis	Drug	0.05 mg intravitreal injection	1	ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity		4 months

Secondary Outcomes

Measure	Description	Time Frame
Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment naive AMD patients;
At least 50 years of age;
Visual acuity between 20/40 and 20/320

Exclusion Criteria:

Pregnancy;
Prior enrollment in a ranibizumab clinical trial;
Previous therapy in either eye for AMD;
Concurrent eye disease that could compromise visual acuity

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

Moran Eye Center Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Bernstein, MD, PhD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Retina Consultants		Santa Barbara	California	93103	United States
Porter Adventist Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23745581	Derived	Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

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