Treating CNV secondary to PM with Lucentis
Research type
Research Study
Full title
A 36 month observational study to describe the long-term efficacy and safety of ranibizumab 0.5mg treatment in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
IRAS ID
173711
Contact name
Rachel Bate
Contact email
Clinicaltrials.gov Identifier
ENCEPP/SDPP/8816, ENCePP registry
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Lucentis® (ranibizumab) was approved for the treatment of visual impairment due to new blood vessels that grow beneath the retina (choroidal neovascularization CNV) secondary to pathologic myopia (PM) on 04 July 13. The European Medicines Agency requested, as a post-approval measure, a 300 patient, 36 month observational study to obtain long-term efficacy and safety data.
The purpose of this study is to collect more information on the use of Lucentis® (ranibizumab) in medical practice for patients suffering from visual impairment due to choroidal neovascularization (CNV) as a result of pathologic myopia (PM).
The study has been designed to investigate how frequently patients are treated with Lucentis® over a period of three years, to determine change in visual acuity and how well Lucentis® is tolerated.
The study will be a non-interventional study collecting routine clinical data over a period of 36 months. No additional procedures will be involved. The study will be carried out in approximately 9 countries, and will involve about 300 patients, approximately 6 sites/ 25 patients in the UK.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0137
Date of REC Opinion
4 Jun 2015
REC opinion
Further Information Favourable Opinion