Advertisement

Suprachoroidal Triamcinolone Acetonide for Diabetic Macular Edema

The HULK Trial
      Injection of corticosteroids into the suprachoroidal space may achieve therapeutic drug levels in the retina while minimizing levels in the anterior parts of the globe.
      • Patel S.R.
      • Berezovsky D.E.
      • McCarey B.E.
      • et al.
      Targeted administration into the suprachoroidal space using a microneedle for drug delivery to the posterior segment of the eye.
      This unique ocular distribution with relative sparing of the anterior parts of the eye has the potential to provide efficacy for posterior segment pathologies while theoretically minimizing the risk of cataract acceleration and intraocular pressure (IOP) elevation associated with intravitreal corticosteroid delivery.
      • Goldstein D.A.
      • Do D.
      • Noronha G.
      • et al.
      Suprachoroidal corticosteroid administration: a novel route for local treatment of noninfectious uveitis.
      • Campochiaro P.A.
      • Wykoff C.C.
      • Brown D.M.
      • et al.
      Suprachoroidal triamcinolone acetonide for retinal vein occlusion: results of the Tanzanite Study.
      The Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination with Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema (HULK) was a phase 1/2, open-label, multicenter clinical trial designed to evaluate the safety and efficacy of suprachoroidal triamcinolone acetonide (CLS-TA), a preservative free, terminally sterilized aqueous suspension (Clearside Biomedical, Alpharetta, GA), as monotherapy or combined with intravitreal aflibercept, in 20 patients with diabetic macular edema (DME; Investigational New Drug identifier, 115683; ClinicalTrials.gov identifier, NCT02949024). All patients provided written informed consent and all study procedures adhered to the tenets set forth in the Declaration of Helsinki and the Health Insurance Portability and Accountability Act. Institutional review board (file 32024; Quorum Review, Seattle, WA) approval was obtained.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic and Personal
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Ophthalmology Retina
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Patel S.R.
        • Berezovsky D.E.
        • McCarey B.E.
        • et al.
        Targeted administration into the suprachoroidal space using a microneedle for drug delivery to the posterior segment of the eye.
        Invest Ophthalmol Vis Sci. 2012; 53: 4433-4441
        • Goldstein D.A.
        • Do D.
        • Noronha G.
        • et al.
        Suprachoroidal corticosteroid administration: a novel route for local treatment of noninfectious uveitis.
        Transl Vis Sci Technol. 2016; 5: 1-8
        • Campochiaro P.A.
        • Wykoff C.C.
        • Brown D.M.
        • et al.
        Suprachoroidal triamcinolone acetonide for retinal vein occlusion: results of the Tanzanite Study.
        Ophthalmol Retina. 2018; 2: 320-328
        • Wells J.A.
        • Glassman A.R.
        • Ayala A.R.
        • et al.
        Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial.
        Ophthalmology. 2016; 123: 1351-1359
        • Maturi R.K.
        • Glassman A.R.
        • Liu D.
        • et al.
        Effect of adding dexamethasone to continued ranibizumab treatment in patients with persistent diabetic macular edema: a DRCR Network phase 2 randomized clinical trial.
        JAMA Ophthalmol. 2018; 136: 29-38