Age related macular degeneration pharmacogenetics study
| ISRCTN | ISRCTN44202629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44202629 |
| Protocol serial number | 7380 |
| Sponsor | Leeds Teaching Hospitals NHS Trust (UK) |
| Funders | National Eye Research Centre (NERC) (UK), Novartis Pharmaceuticals UK Ltd (UK) |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 29/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Martin McKibbin
Scientific
Scientific
Leeds Teaching Hospitals NHS Trust
Department of Opthalmology
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional prevention and treatment trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Genotype and response to treatment for age related macular degeneration (ARMD): a multicentre, non-randomised, interventional, cohort study |
| Study objectives | There has been a major advance in our understanding of the genetic and environmental causes of age related macular degeneration (ARMD). Research has implicated smoking and genetic variants in the complement factor pathway and the HTRA1, vascular endothelial growth factor (VEGF) and a number of other genes of lesser effect, in susceptibility to ARMD. There has also been a parallel advance in the ability to treat this common, blinding disorder using anti-VEGF based treatments, and in particular the VEGF antibody ranibizumab (Lucentis®). This proposal aims to test the hypothesis that response to intravitreal ranibizumab injections in ARMD is, at least in part, modulated by genotype. If genotype does predict response, alternative treatments could be used in those found to benefit least, increasing success rates, saving sight and reducing the need for unnecessary intravitreal injections. |
| Ethics approval(s) | Leeds East Research Ethics Committee approved in February 2009 (ref: 08/H1306/123) |
| Health condition(s) or problem(s) studied | Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology |
| Intervention | This study aims to determine whether genotypes for single nucleotide polymorphisms (SNPs) in the complement factor H, HTRA1 and VEGF genes can predict response to treatment with ranibizumab in patients with ARMD. The visual acuity change from baseline, in ETDRS letters, will be collected from patients who have completed 6 months of treatment for neovascular AMD with intra-vitreal ranibizumab therapy, given in accordance with the EMEA marketing authorisation. DNA will be collected from study particpants and genotyped for SNPs inthe following genes: HTRA1, VEGF and CFH. The data will be analysed to determine if there is evidence of an association between genotype and treatment outcome. Follow-up length: 6 months Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure(s) |
Association of visual acuity letter score change after 6 months of treatment with intra-vitreal ranibizumab and CFH, HTRA1 and VEGF genotype. |
| Key secondary outcome measure(s) |
1. Association of visual acuity letter score change after 6 months of treatment with intra-vitreal ranibizumab and baseline visual acuity |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 350 |
| Key inclusion criteria | 1. Aged over 65 years, either sex 2. Affected with ARM 3. Currently under treatment with ranibizumab (Lucentis) 4. Patients with lesions of greatest linear diameter less than 5400 microns |
| Key exclusion criteria | 1. Patients with poor general health 2. Patients with other eye pathology likely to affect response to treatment 3. Patients with lesions of greatest linear diameter greater than 5400 microns 4. Patients currently being treated with other anti-VEGF agents (systemic or ocular) |
| Date of first enrolment | 31/03/2009 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
