Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept
Study Details
Study Description
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 | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | 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 Names:
Drug: Aflibercept
Intravitreal injection of Aflibercept
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept [1 day]
To determine a genetic basis for patients responsive to ranibizumab but resistant to aflibercept.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Associated Retinal Consultants | Royal Oak | Michigan | United States | 48073 |
Sponsors and Collaborators
- Associated Retinal Consultants, Michigan
- Genentech, Inc.
Investigators
- Principal Investigator: Jeremy D Wolfe, MD, MS, Associated Retinal Consultants
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARCMichigan