Evaluation of the Association Between Genetic Load and Response to Anti-VEGF Therapy in AMD Patients

Age Related Macular Degeneration Clinical Trial

— EVERGREEN  

Official title:

Evaluation of Genetic Variants in Patients Under Treatment for Choroidal Neovascular (CNV) Age-related Macular Degeneration (AMD), Receiving Intravitreal Anti-VEGF Injections (Bevacizumab or Ranibizumab) to Evaluate the Association Between Genetic Load and Response to Therapy/Treatment Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644513
• Other study ID #: SCMM-AMD-105
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: February 11, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Patients with AMD who are being or have been treated with eye injections of drugs known as anti-VEGF agents with either good or poor response will have DNA collected with check swabs for analysis.

Description:

The study is designed as a single-center, observational case control evaluation to compare the genetic profiles of two groups of patients categorized according to anti-VEGF treatment response as either "positive" or "suboptimal" responders following treatment with either bevacizumab or ranibizumab anti-VEGF agents. Positive and suboptimal responders will be compared to determine if genetic variant distribution or total genetic load is associated with anti-VEGF treatment response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Subject is male or female 55 years of age and older

• Subject is self-reported as non-Hispanic Caucasian

• Subject provides a signed and dated informed consent

• Subject agrees to provide two buccal swabs in accordance with this protocol

• Diagnosis of CNV secondary to AMD in at least one eye

• Subject satisfies one of the following:

1. Has received at least one injection of anti-VEGF therapy (bevacizumab or ranibizumab) with no evidence of residual subretinal or intra-retinal fluid present on SDOCT one month (+/- 1 week) following most recent injection; or

2. Has received three or more injections in last six months with residual subretinal or intra-retinal fluid present on SDOCT one month (+/- 1 week) following most recent injection, has not shown complete resolution of fluid following any injection in last 6 months, and shows leakage on FA or ICG imaging at some time during last 12 months.

Exclusion Criteria:

• Previous sample donation under this protocol

• Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50.

• Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate imaging of the posterior segment.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United States	Ophthalmic Consultants Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	Center for Eye Research and Education

Country where clinical trial is conducted

United States,