Vascular Endothelial Growth Factor Trap-Eye for Macular Edema Secondary to Central Retinal Vein Occlusion: Six-Month Results of the Phase 3 COPERNICUS Study

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• 作者：David Boyer ; MD¹ ; Jeffrey Heier ; MD² ; David M. Brown ; MD³ ; W. Lloyd Clark ; MD⁴ ; Robert Vitti ; MD ; MBA⁵ ; Alyson J. Berliner ; MD ; PhD⁵ ; Georg Groetzbach ; MD⁶ ; Oliver Zeitz ; MD⁶ ; ⁷ ; Rupert Sandbrink ; MD ; PhD⁶ ; ⁸ ; Xiaoping Zhu ; PhD⁵ ; Karola Beckmann ; MSc⁶ ; Julia A. Haller ; MD⁹ ; ^{jhaller@willseye.org}
• 刊名：Ophthalmology
• 出版年：2012
• 期刊代码：211_01616420
• 类别：med
• 出版时间：May, 2012
• 卷：119
• 期：5
• 页码：1024-1032
• 文件大小：538 K

摘要

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Objective

To assess the efficacy and safety of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye in eyes with macular edema secondary to central retinal vein occlusion (CRVO).

Design

Multicenter, randomized, prospective, controlled trial.

Participants

One hundred eighty-nine eyes with macular edema secondary to CRVO.

Methods

Eyes were randomized 3:2 to receive VEGF Trap-Eye 2 mg or sham injection monthly for 6 months.

Main Outcome Measures

The proportion of eyes with a 鈮?5-letter gain or more in best-corrected visual acuity (BCVA) at week 24 (primary efficacy end point), mean changes in BCVA and central retinal thickness (CRT), and proportion of eyes progressing to neovascularization of the anterior segment, optic disc, or elsewhere in the retina.

Results

At week 24, 56.1%of VEGF Trap-Eye treated eyes gained 15 letters or more from baseline versus 12.3%of sham-treated eyes (P<0.001). The VEGF Trap-Eye treated eyes gained a mean of 17.3 letters versus sham-treated eyes, which lost 4.0 letters (P<0.001). Central retinal thickness decreased by 457.2 渭m in eyes treated with VEGF Trap-Eye versus 144.8 渭m in sham-treated eyes (P<0.001), and progression to any neovascularization occurred in 0 and 5 (6.8%) of eyes treated with VEGF Trap-Eye and sham-treated eyes, respectively (P = 0.006). Conjunctival hemorrhage, reduced visual acuity, and eye pain were the most common adverse events (AEs). Serious ocular AEs were reported by 3.5%of VEGF Trap-Eye patients and 13.5%of sham patients. Incidences of nonocular serious AEs generally were well balanced between both groups.

Conclusions

At 24 weeks, monthly intravitreal injection of VEGF Trap-Eye 2 mg in eyes with macular edema resulting from CRVO improved visual acuity and CRT, eliminated progression resulting from neovascularization, and was associated with a low rate of ocular AEs related to treatment.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.