Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial

Baruch D. Kuppermann*, Michaella Goldstein, Raj K. Maturi, Ayala Pollack, Michael Singer, Adnan Tufail, Dov Weinberger, Xiao Yan Li, Ching Chi Liu, Jean Lou, Scott M. Whitcup

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To evaluate the efficacy and safety of dexamethasone intravitreal implant 0.7 mg (DEX) as adjunctive therapy to ranibizumab in neovascular age-related macular degeneration (nvAMD). Procedures: This was a 6-month, single-masked, multicenter study. Patients were randomized to DEX implant (n = 123) or sham procedure (n = 120) and received 2 protocol-mandated intravitreal ranibizumab injections. The main outcome measure was injection-free interval to first as-needed ranibizumab injection. Results: DEX increased the injection-free interval versus sham (50th percentile, 34 vs. 29 days; 75th percentile, 85 vs. 56 days; p = 0.016). 8.3% of DEX versus 2.5% of sham-treated patients did not require rescue ranibizumab (p = 0.048). Visual acuity and retinal thickness outcomes were similar in DEX and sham-treated patients. Only reports of conjunctival hemorrhage (18.2 vs. 8.5%) and intraocular pressure elevation (13.2 vs. 4.2%) were significantly different in the DEX versus the sham treatment groups. Conclusion: DEX reduced the need for adjunctive ranibizumab treatment and showed acceptable tolerability in nvAMD patients.

Original languageEnglish
Pages (from-to)40-54
Number of pages15
JournalOphthalmologica
Volume234
Issue number1
DOIs
StatePublished - 25 Sep 2015

Keywords

  • Age-related macular degeneration
  • Choroidal neovascularization
  • Corticosteroid
  • Dexamethasone
  • Intravitreal implant
  • Ranibizumab

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