Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema

David S. Boyer, Young Hee Yoon, Rubens Belfort, Francesco Bandello, Raj K. Maturi, Albert J. Augustin, Xiao Yan Li, Harry Cui, Yehia Hashad, Scott M. Whitcup

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).

Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.

Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.

Methods: Patientswere randomized in a 1:1:1 ratio to study treatmentwithDEX implant 0.7mg,DEX implant 0.35 mg, or shamprocedure andfollowedfor 3 years (or 39months for patients treatedatmonth36) at ≤40 scheduledvisits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.

Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).

Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 mm) and DEX implant 0.35 mg (-107.9 μm) than sham (-41.9 μm; P <0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.

Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Original languageEnglish
Pages (from-to)1904-1914
Number of pages11
JournalOphthalmology
Volume121
Issue number10
DOIs
Publication statusPublished - Oct 1 2014

ASJC Scopus subject areas

  • Ophthalmology

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