Evaluation of the Association Between Genetic Load and Response to Anti-VEGF Therapy in AMD Patients (EVERGREEN)
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.
Age Related Macular Degeneration
|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|
Remnant samples of DNA will be destroyed after analysis is complete.
|Study Start Date:||July 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644513
|United States, Massachusetts|
|Ophthalmic Consultants Boston|
|Boston, Massachusetts, United States, 02114|