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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644513
First Posted: July 19, 2012
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Center for Eye Research and Education
Information provided by (Responsible Party):
Sequenom, Inc.
  Purpose
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.

Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Sequenom, Inc.:

Biospecimen Retention:   None Retained
Remnant samples of DNA will be destroyed after analysis is complete.

Enrollment: 196
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Positive Responders
Have received at least one injection with no evidence of residual subretinal or intra-retinal fluid present on Spectral Domain Optical Coherence Tomography (SDOCT) one month (+/- 1 week) following most recent injection.
Suboptimal Responders
Have 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; Have not demonstrated complete resolution of fluid following any of the injections in the last 6 months Show leakage on Fluorescein Angiography (FA) or Indocyanine Green (ICG) imaging at some time during last 12 months

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with age-related macular degeneration treated with anti-VEGF therapy
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644513


Locations
United States, Massachusetts
Ophthalmic Consultants Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Sequenom, Inc.
Center for Eye Research and Education
  More Information

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01644513     History of Changes
Other Study ID Numbers: SCMM-AMD-105
First Submitted: July 17, 2012
First Posted: July 19, 2012
Last Update Posted: February 12, 2013
Last Verified: July 2012

Keywords provided by Sequenom, Inc.:
Age Related Macular Degeneration
Choroidal Neovascular
anti-VEGF Therapy

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents