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Baruch D. Kuppermann, Julia A. Haller, Francesco Bandello, Rubens Belfort, Jr., Anat Loewenstein, Mark Gillies,, Jeffrey S. Heier, Jenny Jiao, Xiao-Yan Li, Scott M. Whitcup; Efficacy of Dexamethasone Intravitreal Implant for Best Corrected Visual Acuity in Patients With Retinal Vein Occlusion After 7 Days. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3966.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate efficacy 7 days after treatment of dexamethasone intravitreal (DEX) implant (Ozurdex®) 0.7 mg compared with sham procedure in patients with vision loss due to macular edema (ME) following retinal vein occlusion (RVO).
Patients ≥ 18 years with fovea-involved ME due to BRVO or CRVO, BCVA between 34 (20/200) and 68 letters (20/50), and retinal thickness of ≥ 300 µm enrolled into 2 identical 6-month, randomized, prospective, multicenter, masked, sham-controlled, parallel-group clinical trials. Patients received either DEX implant 0.7 mg or sham procedure.
427 patients (68% BRVO; 32% CRVO) received DEX implant and 426 (66% BRVO; 34% CRVO) received sham procedure. Baseline mean BCVA was 54.3 letters (20/80) and 54.8 letters (20/80) in the DEX implant and sham arms, respectively. At day 7, mean improvement in BCVA was 5.3 letters and 1.6 letters in the DEX implant and sham arms, respectively (P ≤ .001). In the DEX implant and sham arms, mean improvement in BCVA was 5.1 letters and 2.3 letters in BRVO patients (P ≤ .001) and 5.8 letters and 0.08 letters in the DEX implant and sham arms in CRVO patients (P ≤ .001), respectively. The proportion of eyes achieving improvement in BCVA of ≥ 10 letters from baseline at day 7 in the DEX implant/sham arms were 27% and 11%, respectively (P ≤ .001). The proportion of eyes achieving improvement in BCVA of ≥ 15 letters was 10% and 5% in the DEX implant and sham arms, respectively (P = .025) in BRVO patients and 11% and 2% (P = .002) in CRVO patients.
Significant improvements in BCVA were noted as early as 7 days after implantation of DEX implant in patients with RVO.
Clinical Trial: :
http://www.clinicaltrials.gov 00168298 & 00168324
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