A study to evaluate THR-317 and Lucentis combination treatment for DMO
Research type
Research Study
Full title
A Phase 2, randomised, single-masked, active controlled, multicentre study to evaluate the efficacy and safety of intravitreal THR-317 administered in combination with ranibizumab, for the treatment of diabetic macular oedema (DME)
IRAS ID
239305
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
ThromboGenics NV
Eudract number
2017-003897-15
Duration of Study in the UK
0 years, 10 months, 0 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 (DMO). In people with DMO, 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 DMO 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 DMO. There are however patients for whom anti-VEGF drugs do not work so well.
THR 317 (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 317 is called placental growth factor. This is the second clinical research study in which THR-317 is injected in the eye for the treatment of DMO. The study is being done to check if the combination of THR-317 with the anti-VEGF Lucentis® could be a good treatment for people with DMO. In order to understand the effect of the combination treatment, it will be compared with treatment with Lucentis® alone. Participants will be randomly assigned (according to a 2:1 ratio) to the combination treatment or to Lucentis® treatment alone.
72 patients will take part in the study in different countries across Europe. Participants will be asked to attend the study site 9 times during a period of about 4,5 to 6 months. During the study, participants will be asked to answer medical questions, have various eye examinations in both eyes, have blood samples taken as well as have their blood pressure measured.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0410
Date of REC Opinion
23 Apr 2018
REC opinion
Further Information Favourable Opinion