Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Ranibizumab; Drug: Aflibercept

• Registration Number: NCT02291887
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Study Start: 2014-12-22
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neovascular ARMD Patients	Ranibizumab	Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment
Neovascular ARMD Patients	Aflibercept	Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Associated Retinal Consultants; 🇺🇸 Royal Oak, Michigan, United States