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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

    n.lois@qub.ac.uk

  • Sponsor organisation

    Belfast Health & Social Care 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