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)

Abstract

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