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

Sponsor
Sequenom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01644513
Collaborator
Center for Eye Research and Education (Other)
196
Enrollment
1
Location
5
Duration (Months)
39
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    196 participants
    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
    Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      55 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Ophthalmic Consultants Boston Boston Massachusetts United States 02114

      Sponsors and Collaborators

      • Sequenom, Inc.
      • Center for Eye Research and Education

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Sequenom, Inc.
      ClinicalTrials.gov Identifier:
      NCT01644513
      Other Study ID Numbers:
      • SCMM-AMD-105
      First Posted:
      Jul 19, 2012
      Last Update Posted:
      Feb 12, 2013
      Last Verified:
      Jul 1, 2012
      Keywords provided by Sequenom, Inc.
      Age Related Macular Degeneration
      Choroidal Neovascular
      anti-VEGF Therapy
      Additional relevant MeSH terms:
      Macular Degeneration

      Study Results

      No Results Posted as of Feb 12, 2013