Clinical trial NCT01644513: Evaluation of the Association Between Genetic Load and Response to Anti-VEGF Therapy in AMD Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: Age Related Macular Degeneration
Choroidal Neovascular
anti-VEGF Therapy
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Center for Eye Research and Education
First posted: 2012-07-19
Enrollment: 196
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with age-related macular degeneration treated with anti-VEGF therapy

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants Boston
state: Massachusetts
Study officials:
References: