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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:
Collaborator:
Center for Eye Research and Education
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01644513
First received: July 17, 2012
Last updated: February 11, 2013
Last verified: July 2012
History of Changes
  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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01644513     History of Changes
Other Study ID Numbers: SCMM-AMD-105
Study First Received: July 17, 2012
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013