Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment
Age-Related Macular Degeneration Drug: Ranibizumab Drug: 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab But Resistant to Aflibercept
Actual Study Start Date : December 22, 2014
Actual Primary Completion Date : July 1, 2015
Actual Study Completion Date : July 1, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Neovascular ARMD Patients
Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment
Drug: Ranibizumab
Intravitreal injection of Ranibizumab
Other Name: Lucentis

Drug: Aflibercept
Intravitreal injection of Aflibercept
Other Name: Eylea




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood from each patient will be drawn for genetic analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291887


Locations
Layout table for location information
United States, Michigan
Associated Retinal Consultants
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Associated Retinal Consultants, Michigan
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jeremy D Wolfe, MD, MS Associated Retinal Consultants
Publications of Results:
Layout table for additonal information
Responsible Party: Associated Retinal Consultants, Michigan
ClinicalTrials.gov Identifier: NCT02291887    
Other Study ID Numbers: ARCMichigan
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents