Purchase this article with an account.
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.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Evaluate the effect of OZURDEX (dexamethasone intravitreal implant) 0.7 mg when given with Lucentis® (ranibizumab) in exudative AMD.
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.
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).
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: :
This PDF is available to Subscribers Only