Evaluation of the Association Between Genetic Load and Response to Anti-VEGF Therapy in AMD Patients
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | July 2012 |
| End Date: | December 2012 |
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
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.
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.
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.
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