Do genes predict response to treatment in age-related macular degeneration? - ARMD pharmacogenetics

• Conditions: Choroidal neovascularisation secondary to age-related macular degeneration (ARMD)

• Registration Number: EUCTR2008-007319-33-GB
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Written informed consent
Age over 65 years
Choroidal neovascularisation secondary to Age-related macular degeneration (ARMD)
Lesion size less than 5400 microns
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of informed consent
Lesion size greater than 5400 microns at baseline
Other ocular pathology likely to influence visual acuity after treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the change in visual acuity after 6 months of treatment with ranibizumab injections, used in accordance with the SPC and Marketing authorisation, with genotype. ;Secondary Objective: To compare the number of injections of ranibizumab given over the initial 6 months of treatment with genotype.;Primary end point(s): This is a pilot project to test the hypothesis that response to intravitreal ranibizumab injections for ARMD, provided in accordance with current NHS practice and the product license, varies according to genotype. It is hoped that this study will provide pilot data to support more detailed analysis of a larger cohort subsequently.<br><br>The aim is to determine the change in visual acuity after 6 months of intra-vitreal ranibizumab therapy and see if this relates to genetic polymorphisms in 3 genes implicated in contributing to the development of ARMD, namely CFH, HTRA1 and VEGF.