• linkedin
  • Increase Font
  • Sharebar

    Does dexamethasone implant add benefit in ranibizumab patients?


    DRCR Network Protocol U

    Protocol U was a phase II multicenter, randomized trial conducted from February 2014 to December 2016. A total of 129 eyes of 116 patients (median age, 65 years) with types 1 and 2 diabetes were included. The visual acuity levels ranged from 20/32 to 20/320.

    Previous to inclusion in this trial, all patients had undergone treatment with a minimum of 3 anti-VEGF injections to treat DME during the preceding 20 weeks. Those drugs included aflibercept (Eylea Pharmaceuticals), ranibizumab, and bevacizumab (Avastin, Genentech).

    Eyes with persistent DME that met the study inclusion criteria were entered into a run-in phase that lasted 12 weeks, during which another 3 injections of intravitreal ranibizumab (0.3 mg) were given–one injection when the patient was enrolled and injections at 4 and 8 weeks.

    At the end of the 12-week period, the eyes that had been treated with the 3 additional injections and still had a central subfield thickness (CST) greater than the threshold defined by the protocol were then randomized to either an intravitreal injection of the combination of ranibizumab (0.3 mg) plus dexamethasone (700 µg) or to ranibizumab (0.3 mg) plus sham therapy.

    The patients were examined every 4 weeks for 24 weeks. Besides an ocular examination, the examinations included spectral-domain OCT, measurement of the best-corrected visual acuity and intraocular pressure (IOP), Dr. Bakri explained.

    The main outcome measure was the mean change in the visual acuity letter score at 24 weeks, and the secondary outcome was the change in the mean CST.


    Lynda Charters
    Lynda Charters is a freelance medical writer.


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available

    Latest Tweets Follow

    var script= ' ';