COLUMBUS-AMD
Research type
Research Study
Full title
Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)
IRAS ID
184390
Contact name
Clare Bailey
Contact email
Sponsor organisation
Bioeq GmbH
Eudract number
2015-001961-20
Clinicaltrials.gov Identifier
FMY001, CRO Trial Code (TFS)
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
AMD, (age-related macular degeneration) is a progressive degenerative macular disease affecting the region of highest visual acuity (VA) of the eye. It is a disease affecting individuals over 50 years of age. AMD is caused by a problem with part of the eye called the macula. The macula is the spot at the centre of the retina (the nerve tissue lining the back of the eye) and the macula plays an essential role in helping see things directly in front of you and is used for closed, detailed activities, such as reading and writing. There are two different types of age related macular degeneration. The first type is called “dry” macular degeneration. The second type, called “wet” macular degeneration, which is the one evaluated in this clinical trial, is characterized by blood vessels that grow under the retina in the back of the eye, leaking blood and fluid. This study has been designed to evaluate the ranibizumab biosimilar medicine (FYB201) in comparison to the approved ranibizumab reference medicine (Lucentis) for the treatment of wet AMD. Both products have the same pharmaceutical composition, applied dosing, and strength.
The goal of the study is to show that the ranibizumab biosimilar (FYB201) is as good, safe and effective as the reference medicine ranibizumab (Lucentis).
This study will be carried out at approximately 80 sites in Europe, Russia, Israel and North America. The study will start in Quarter 4 2015, when the first patient is expected to enter the study, and will end in Quarter 2 2018, when the last patient is expected to have the last visit. A total of 650 patients are planned to be randomised. Patients who enter the study will need to have newly diagnosed, still untreated "wet" AMD. They will be treated over a 12 month period with monthly intra vitreal injections of FYB201 or Lucentis every 4 weeks. The total duration of the trial for each patient will be around 48 weeks. There will be a subgroup, at some selected sites, in which the amount of drug in the blood will be quantified at some different time points (these patients will need to attend 2 extra visits). Patients (not participating in the subgroup) will attend 14 study visits, and those participating, 16 visits.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0437
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion