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

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.

• Authors: 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, Ozurdex® ERIE Study Group
• Journal: Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde (Ophthalmologica) Vol. 234 Issue 1 Pg. 40-54 ( 2015) ISSN: 1423-0267 [Electronic] Switzerland
• PMID: 26088793 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 S. Karger AG, Basel.

Chemical References

• Angiogenesis Inhibitors
• Ranibizumab

Topics

• Aged, 80 and over
• Angiogenesis Inhibitors (administration & dosage)
• Female
• Fluorescein Angiography
• Follow-Up Studies
• Fundus Oculi
• Humans
• Intravitreal Injections
• Male
• Ranibizumab (administration & dosage)
• Retrospective Studies
• Time Factors
• Tomography, Optical Coherence
• Treatment Outcome
• Visual Acuity
• Wet Macular Degeneration (diagnosis, drug therapy)