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

NCT01644513 | Completed

• 1 other identifier: SCMM-AMD-105
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

Age Related Macular Degeneration; Choroidal Neovascular; anti-VEGF Therapy

Study Arms (2)

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with age-related macular degeneration treated with anti-VEGF therapy

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sequenom, Inc.: lead
• Center for Eye Research and Education: collaborator

Study Sites (1)

Ophthalmic Consultants Boston

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: NONE RETAINED

Remnant samples of DNA will be destroyed after analysis is complete.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 12, 2013

Record last verified: 2012-07

Locations

US (1)