NCT02291887

Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Associated Retinal Consultants, Michigan · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	Intravitreal injection of Ranibizumab
DRUG	Aflibercept	Intravitreal injection of Aflibercept

Timeline

• Start date: 2014-12-22
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-11-17
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States