Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept
NCT ID: NCT02291887
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
13 participants
OBSERVATIONAL
2014-12-22
2015-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neovascular ARMD Patients
Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment
Ranibizumab
Intravitreal injection of Ranibizumab
Aflibercept
Intravitreal injection of Aflibercept
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranibizumab
Intravitreal injection of Ranibizumab
Aflibercept
Intravitreal injection of Aflibercept
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Associated Retinal Consultants, Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeremy D Wolfe, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Associated Retinal Consultants
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Associated Retinal Consultants
Royal Oak, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Eyetech Study Group. Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: phase II study results. Ophthalmology. 2003 May;110(5):979-86. doi: 10.1016/S0161-6420(03)00085-X.
Rosenfeld PJ, Rich RM, Lalwani GA. Ranibizumab: Phase III clinical trial results. Ophthalmol Clin North Am. 2006 Sep;19(3):361-72. doi: 10.1016/j.ohc.2006.05.009.
Michels S, Schmidt-Erfurth U, Rosenfeld PJ. Promising new treatments for neovascular age-related macular degeneration. Expert Opin Investig Drugs. 2006 Jul;15(7):779-93. doi: 10.1517/13543784.15.7.779.
Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology. 2006 Apr;113(4):623.e1. doi: 10.1016/j.ophtha.2006.01.027.
Heier JS, Antoszyk AN, Pavan PR, Leff SR, Rosenfeld PJ, Ciulla TA, Dreyer RF, Gentile RC, Sy JP, Hantsbarger G, Shams N. Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology. 2006 Apr;113(4):633.e1-4. doi: 10.1016/j.ophtha.2005.10.052. Epub 2006 Feb 14.
Feigl B, Brown B, Lovie-Kitchin J, Lee L. Dynamics of retinal function after multiple photodynamic therapies in age-related macular degeneration: a report of cases. Doc Ophthalmol. 2005 Nov;111(3):135-48. doi: 10.1007/s10633-005-5319-7. Epub 2006 Mar 6.
D'Amico DJ. Diseases of the retina. N Engl J Med. 1994 Jul 14;331(2):95-106. doi: 10.1056/NEJM199407143310207. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARCMichigan
Identifier Type: -
Identifier Source: org_study_id