POINT, v1.1 06Aug15

  • Research type

    Research Study

  • Full title

    Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial

  • IRAS ID

    181778

  • Contact name

    Susan Lightman

  • Contact email

    s.lightman@ucl.ac.uk

  • Sponsor organisation

    MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health

  • Eudract number

    2016-000304-29

  • Clinicaltrials.gov Identifier

    NCT02374060

  • Clinicaltrials.gov Identifier

    14/0840, V1.0 21 Dec 2015, UCL Protocol Addendum

  • Duration of Study in the UK

    1 years, 10 months, 29 days

  • Research summary

    This research is being done to compare three treatments for macular edema in patients who have the eye condition uveitis (inflammation inside the eye). All three treatments are commonly used to treat macular edema.
    Macular edema is swelling of the retina at the back of the eye. It can cause vision loss and is a common complication in patients who have the eye condition uveitis (inflammation inside the eye). The standard treatments are to inject corticosteroid drugs next to the eye or directly into the eye. Many doctors believe that intravitreal (into the eye) injections work better than periocular (near the eye) injections. However, injections into the eye may have more side effects.
    A corticosteroid drug called triamcinolone acetonide often is used for both kinds of injections. Another kind of corticosteroid drug used is dexamethasone. For dexamethasone, an applicator is used to put a small pellet of drug inside the eye. The drug pellet dissolves over time. All three treatments are commonly used by doctors to treat macular edema and are part of standard care for uveitis. In this study we will compare these three treatments to find out which one is the safest and works best.
    The study will assess effectiveness of the treatment by measuring macular thickness. Secondary outcomes will include resolution of macular swelling, visual acuity, pressure in the eye, complications of treatment and cost effectiveness.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    16/SC/0106

  • Date of REC Opinion

    5 Apr 2016

  • REC opinion

    Further Information Favourable Opinion