TREND
Research type
Research Study
Full title
A 12-month, phase IIIb, randomized, visual acuity, assessor-masked, multicenter study assessing the efficacy and safety of ranibizumab 0.5mg in treat and extend regimen compared to monthly regimen, in patients with neovascular age-related macular degeneration
IRAS ID
144027
Contact name
James Warburton
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-002626-23
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
Age-related macular degeneration (AMD) is the leading cause of severe loss of vision in the elderly. The disease affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). The disease particularly affects the macula, a section of the retina crucial for central vision (such as reading and driving).
There are 2 forms of this disease, commonly known as ’wet’ and ’dry’ forms. Wet AMD (otherwise known as neovascular AMD) is characterised by abnormal blood vessel growth and blood and protein leakage in the macula, which in turn can lead to irreversible retinal damage and vision loss if left untreated.
The new blood vessel formation requires a protein called vascular endothelial growth factor (VEGF), which is produced in high quantity in wet AMD. Ranibizumab is a drug which is injected into the eye and works by blocking the effects of VEGF.
This is a 12 month study which will compare 2 different treatment regimens with 0.5mg ranibizumab (Lucentis) for the treatment of wet AMD. Group 1 will received ranibizumab every month. Group 2 will receive ranibizumab in a Treat and Extend Regimen (TER). The patients will be treated until there is absence of disease activity. Thereafter, the treatment interval will be extended by 2 weeks at each visit as long as there is still no disease activity. If disease activity is present, the treatment interval will be shortened by 2 weeks.
Patients aged 50 years and over will be included in the study with a target for the UK 50 over approx. 10 sites. Patients will be asked to attend the clinic for at least 14 visits over the 12 month study period.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/0001
Date of REC Opinion
6 Feb 2014
REC opinion
Further Information Favourable Opinion