Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab But Resistant to Aflibercept

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neovascular ARMD Patients<br>Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment | Drug: Ranibizumab<br>* Intravitreal injection of Ranibizumab<br>* Other names: Lucentis;Drug: Aflibercept<br>* Intravitreal injection of Aflibercept<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept | To determine a genetic basis for patients responsive to ranibizumab but resistant to aflibercept. | 1 day |