Choroidal neovascularisation secondary to age-related macular degeneration (ARMD)
Conditions
Interventions
Trade Name: Ranibizumab (Lucentis)
Pharmaceutical Form: Solution for injection
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Lack of informed consent Lesion size greater than 5400 microns at baseline Other ocular pathology likely to influence visual acuity after treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
United Kingdom
Outcome results
None listed