The use of ARA 290 for the treatment of DMO (ARA 290-DMO) v1
Research type
Research Study
Full title
A phase II Clinical Trial on the use of ARA 290 for the treatment of diabetic macular oedema (ARA 290-DMO)
IRAS ID
180422
Contact name
Noemi Lois
Contact email
Sponsor organisation
Belfast HSC Trust
Eudract number
2015-001940-12
ISRCTN Number
ISRCTN16962255
Duration of Study in the UK
1 years, 3 months, days
Research summary
Diabetic retinopathy is the most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR); both are complications of diabetes in the eye.
In DMO fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates the sight drops.
The current treatments for DMO include laser and “anti-VEGF” drugs. Anti-VEGF drugs have been very helpful in the treatment of DMO. However, anti-VEGF drugs need to be given by an injection into the eye; an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) needs to treat patients with DMO in the hospital. Furthermore, patients require injections every four weeks during the first months of treatment and long-term treatment is required. Moreover, not all patients respond to anti-VEGFs: In 40-50% of patients the sight does not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
Given the above facts there is a clear need to develop new treatments for people with DMO.
ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, ARA 290 could potentially be helpful in treating patients with this condition. In light of this, we are carrying out this study to find out if ARA 290 is effective in drying the fluid in DMO. If this treatment is successful, benefits may include a reduction of the demands on health care services and patient benefits of: a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment.
REC name
HSC REC B
REC reference
15/NI/0197
Date of REC Opinion
21 Oct 2015
REC opinion
Favourable Opinion