April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Safety and Efficacy of OZURDEXTM (Dexamethasone Intravitreal Implant) as Adjunctive Therapy to Lucentis® in Patients With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Author Affiliations & Notes
  • A. Loewenstein
    Ophthalmology, Tel-Aviv Medical Center, Tel Aviv, Israel
  • B. D. Kuppermann
    Gavin Herbert Eye Inst Dept Ophthalmolog, University of California Irvine, Irvine, California
  • D. Weinberger
    Ophthalmology, Rabin Medical Ctr, Petach Tikva, Israel
  • M. Goldstein
    Ophthalmology, Tel-Aviv Medical Center, Tel-Aviv, Israel
  • M. Singer
    Medical Center Ophthalmology Associates, San Antonio, Texas
  • C.-C. Liu
    Allergan, Inc, Irvine, California
  • J. Lou
    Allergan, Inc, Irvine, California
  • X.-Y. Li
    Clinical Ophthalmology,
    Allergan, Inc, Irvine, California
  • S. M. Whitcup
    R & D,
    Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  A. Loewenstein, Allergan, Notal Vision, C; Novrtis, Alcon, R; B.D. Kuppermann, Allergan, CoMentis, Genentech, Glaukos, Neovista, Novagali, SurModics, TargeGen, Opthotech, OPKO Health, Vitreoretinal Technologies, C; D. Weinberger, None; M. Goldstein, Bayer Schering, Novartis, Notal Vision, R; M. Singer, Genentech, Regeneron, NeoVista, Macusight, F; Allergan, ISTA, Alcon, Genentech, C; C.-C. Liu, Allergan, E; J. Lou, Allergan, E; X.-Y. Li, Allergan, E; S.M. Whitcup, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 1255. doi:
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      A. Loewenstein, B. D. Kuppermann, D. Weinberger, M. Goldstein, M. Singer, C.-C. Liu, J. Lou, X.-Y. Li, S. M. Whitcup; Safety and Efficacy of OZURDEXTM (Dexamethasone Intravitreal Implant) as Adjunctive Therapy to Lucentis® in Patients With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2010;51(13):1255.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : Evaluate the effect of OZURDEX (dexamethasone intravitreal implant) 0.7 mg when given with Lucentis® (ranibizumab) in exudative AMD.

Methods: : This 6-month, randomized, single-masked, multicenter, sham-controlled study enrolled patients requiring ranibizumab treatment for CNV secondary to AMD. At screening, all patients received an intravitreal injection of ranibizumab 0.5 mg. 4 weeks later at the baseline (day 1) visit, patients who met OCT and clinical examination criteria for retreatment with ranibizumab were randomized to receive DEX Implant (n=123) or sham procedure (n=120). Patients were given a second ranibizumab injection 7-14 days after the baseline visit. For patients meeting retreatment criteria, up to 5 additional ranibizumab injections were given prior to study exit (week 25). Primary efficacy outcome measure was injection-free interval.

Results: : Adjunctive therapy with DEX Implant statistically significantly delays first as-need ranibizumab injection based on Kaplan-Meier product-limit method (P = .016). The 75th percentile of injection-free interval was 12 weeks in DEX Implant group vs 8 weeks in control group over 6 months. Relative risk of not requiring additional as-needed ranibizumab injection was 3.28 (DEX Implant vs sham, P = .048). Treatment-related adverse events were similar between groups, except: increased IOP (9.9% vs 3.4%) and conjunctival hemorrhage (6.6% vs 0.8%) in the DEX Implant group vs control group (P </= .044).

Conclusions: : DEX Implant delayed the time to as-needed injection of ranibizumab and reduced the need for repeated ranibizumab treatment in patients with CNV secondary to AMD.

Clinical Trial: : www.clinicaltrials.gov NCT00333814

Keywords: choroid: neovascularization • corticosteroids • neovascularization 

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