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Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291887
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Associated Retinal Consultants, Michigan

Tracking Information
First Submitted Date November 12, 2014
First Posted Date November 17, 2014
Last Update Posted Date November 17, 2017
Actual Study Start Date December 22, 2014
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2017)
Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept [ Time Frame: 1 day ]
To determine a genetic basis for patients responsive to ranibizumab but resistant to aflibercept.
Original Primary Outcome Measures
 (submitted: November 12, 2014)
Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept [ Time Frame: 1 day ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept
Official Title Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab But Resistant to Aflibercept
Brief Summary

A cohort of patients responsive to treatment with ranibizumab but resistant to

aflibercept were identified in a previously conducted retrospective study. Identified

patients will have their blood drawn for genome wide sequencing. The sequencing

data will be compiled and analyzed in an attempt to identify a common genetic basis

for patients susceptible to ranibizumab but resistant to aflibercept.

Detailed Description

A cohort of patients responsive to treatment with ranibizumab but resistant to

aflibercept were identified in a previously conducted retrospective study. Identified

patients will have their blood drawn for genome wide sequencing. The sequencing

data will be compiled and analyzed in an attempt to identify a common genetic basis

for patients susceptible to ranibizumab but resistant to aflibercept.

Blood samples will be drawn for genetic analysis for all patients enrolled in the study.

The sample (1 tube- 6mL of blood) will be collected using - 8.5mL PAXgene Blood DNA

Tubes (http://www.qiagen.com/products/catalog/sample-technologies/dna-sample-

technologies/genomic-dna/paxgene-blood-dna-tubes).

Samples will be stored at -80 until time for analysis. Note that some blood draws will be performed at

satellite clinics and transported to main facility for storage in -80 freezer. It is the understanding of

ARC PI and staff that the PAXgene Blood DNA Tubes keep samples stable at room temp for 1-2

days.

However, staff will transport samples in timely fashion (room temp, on ice, dry ice,

etc), to -80 freezer for storage until all samples are collected. Once all samples are

collected, they will be shipped to Genentech for analysis. DNA extraction, the generation of genetic

data, and subsequent analysis will be performed at Genentech or via third party. DNA will be assayed

for polymorphisms through genome wide SNP chip or whole genome sequencing. The subject's

genotype or haplotype will be correlated with their visual response and OCT response.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood from each patient will be drawn for genetic analysis.
Sampling Method Non-Probability Sample
Study Population 17 subjects from approximately 1 site in the United States will be enrolled. Eligible subjects will be administered and provided with a copy of informed consent.
Condition Age-Related Macular Degeneration
Intervention
  • Drug: Ranibizumab
    Intravitreal injection of Ranibizumab
    Other Name: Lucentis
  • Drug: Aflibercept
    Intravitreal injection of Aflibercept
    Other Name: Eylea
Study Groups/Cohorts Neovascular ARMD Patients
Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment
Interventions:
  • Drug: Ranibizumab
  • Drug: Aflibercept
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 15, 2017)
13
Original Estimated Enrollment
 (submitted: November 12, 2014)
17
Actual Study Completion Date July 1, 2015
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects will be eligible if the following criteria are met:

    • Demonstrate worsening of exudation when switched from ranibizumab to aflibercept
    • Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

  • Any other condition that the investigator believes would pose a significant hazard to the subject
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02291887
Other Study ID Numbers ARCMichigan
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Associated Retinal Consultants, Michigan
Study Sponsor Associated Retinal Consultants, Michigan
Collaborators Genentech, Inc.
Investigators
Principal Investigator: Jeremy D Wolfe, MD, MS Associated Retinal Consultants
PRS Account Associated Retinal Consultants, Michigan
Verification Date November 2017