`VEGF Trap in Subjects With Diabetic Macular
`Edema: The CLEAR-IT DME Study
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`Abstract
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`Samsung Bioepis Exhibit 1030
`Page 1
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`FREE
`ARVO Annual Meeting Abstract | May 2007
`D. V. Do;
`Q. D. Nguyen; D. J. Browning; J. A. Haller; K. Chu; J. Buskey; I. Grimes; A. Ingerman; J. Cederbaum; P. A.
`Campochiaro
`Author A liations & Notes
`Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1430. doi:
`Purpose:: To determine the safety, tolerability, and bioactivity of a single dose (4.0mg) of
`intravitreal VEGF Trap in patients with diabetic macular edema (DME).
`Methods:: Five patients with DME, foveal thickness
` 250µm measured by optical
`coherence tomography (OCT) and ETDRS best-corrected visual acuity (BCVA) of
` 20/40 and
` 20/320 were administered a single intravitreal injection of 4 mg VEGF Trap at day 0.
`Safety assessments included eye examinations, vital signs, and laboratory tests. Measures
`of bioactivity included changes from baseline in BCVA, centerpoint retinal thickness (CRT),
`and leakage
`on uorescein angiography. Subjects were monitored for 6 weeks following
`VEGF Trap administration.
`Results:: Mean patient age was 65.2 years (range=56-75); 4 were Type 2 diabetics. Mean
`duration of diabetes prior to treatment was 26 years. All had received prior treatment for
`DME. No severe ocular or serious systemic adverse events related to study drug were
`noted. Mean baseline BCVA was 69 letters and mean baseline CRT was 407µm. Four
`patients had improvements in BCVA, ranging from 6 to 10 letters at 4 weeks post-injection.
`The mean decrease in centerpoint retinal thickness was 115µm at 4 weeks.
`Conclusions:: A single intravitreal dose of VEGF Trap was well-tolerated and led to a
`reduction in CRT and an improvement in BCVA. Although the number of subjects is small,
`preliminary evidence for bioactivity of VEGF Trap in patients with DME was detected.
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`Samsung Bioepis Exhibit 1030
`Page 2
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`Additional studies are being planned to identify the potential therapeutic role of
`intravitreal VEGF Trap in DME.
`Clinical Trial::
`www.clinicaltrials.gov NCT 00320814
`Keywords: diabetic retinopathy • macula/fovea • clinical (human) or epidemiologic studies:
`treatment/prevention assessment/controlled clinical trials
`© 2007, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.
`Permission to republish any abstract or part of an abstract in any form must be obtained in
`writing from the ARVO O ce prior to publication.
`
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