A study to evaluate THR-149 treatment for diabetic macular oedema
Research type
Research Study
Full title
A Phase 2, randomised, multicentre study to assess the dose level of multiple THR-149 injections and to evaluate the efficacy and safety of THR-149 versus aflibercept for the treatment of diabetic macular oedema (DME)
IRAS ID
280277
Contact name
Geeta Menon
Contact email
Sponsor organisation
Oxurion NV
Eudract number
2019-001506-17
Duration of Study in the UK
1 years, 9 months, 22 days
Research summary
Diabetes can cause damage to blood vessels in the back of the eye, which can eventually lead to blindness. One of the eye problems caused by diabetes is called diabetic macular oedema (DME). In people with DME, blood vessels in the back of the eye are leaking, leading to an accumulation of fluid, which leads to vision problems. The current gold standard treatment for DME are anti-VEGF drugs. Anti-VEGF drugs block a protein called vascular endothelial growth factor (VEGF), which can stimulate blood vessels to leak fluid. Anti VEGF drugs have few side effects and have been very helpful in the treatment of DME. There are however patients for whom anti-VEGF drugs do not work so well.
THR-149 (the study drug) works in a similar way as anti VEGF drugs, as it also blocks a protein that can stimulate blood vessels to leak fluid. The protein blocked by THR-149 is called plasma kallikrein. This is the second clinical research study in which THR-149 is injected in the eye for the treatment of DME. The study is being done to check if THR-149 could be a good treatment for people with DME. In order to understand if THR-149 is a better treatment for DME than anti-VEGFs, it will be compared with Eylea (anti-VEGF).
Participants will be randomly assigned – according to 1:1:1 ratio in Part A to 3 different doses of THR-149 and a 1:1 ratio in Part B to THR-149 or Eylea.
122 patients will take part in the study in different countries across Europe and USA. Participants will be asked to attend the study site 8 times during a period of about 6 months. During the study, participants will be asked to answer medical questions, have various eye examinations, have blood samples taken and have their blood pressure measured.
REC name
Wales REC 2
REC reference
20/WA/0145
Date of REC Opinion
22 Jun 2020
REC opinion
Further Information Favourable Opinion