`INvestigation of Clinical Impact: Phase 2
`Study in Patients With Diabetic Macular
`Edema (DME)
`
`
`
`Abstract
`
`Celltrion Exhibit 1010
`Page 1
`
`FREE
`ARVO Annual Meeting Abstract | April 2010
`J. C. Major, Jr.; D. M. Brown; DA VINCI Study Group
`Author A liations & Notes
`Investigative Ophthalmology & Visual Science April 2010, Vol.51, 6426. doi:
`Purpose: : VEGF Trap-Eye (VTE) is a recombinant fusion protein consisting of VEGF binding
`domains of human VEGF receptors 1 and 2 fused to the Fc domain of human IgG1. This
`phase 2 study assesses
`the e cacy and safety of intravitreal VTE vs. laser
`photocoagulation in DME at the 24-week primary endpoint.
`Methods: : DA VINCI is a multi-center, randomized, active-controlled Phase 2 clinical study,
`designed to assess safety and e cacy of 4 dose/dose intervals of VTE in comparison to
`laser photocoagulation. 221 patients were randomized (219 treated) to 1 of the following
`treatment arms: 0.5mg q4wks, 2mg q4wks, 2mg q8wks, 2mg prn or laser
`photocoagulation. The primary endpoint is the mean change from baseline in BCVA at
`week 24. Secondary endpoints include changes in retinal thickness (CRT) on OCT and
`central retinal sensitivity. Central retinal sensitivity was measured using the Nidek MP-1
`microperimeter with values corresponding to the
`OCT central sub eld.
`Results: : At 6 months, the mean change in BCVA for each VTE arm ranged from +8.5 to
`+11.4 letters and was statistically signi cantly better than the mean change in BCVA in the
`laser arm (+2.5 letters;
`p<0.01). No signi cant di erence was noted among the VTE arms.
`Anatomical e ects (mean change in CRT) for each VTE arm ranged from -127µm to -195µm
`and were signi cantly greater than the mean change in CRT for the laser arm (-68µm;
`p<0.01). VTE arms had a mean gain in central retinal sensitivity ranging from 1.5 to 4.1dB,
`
`
`Celltrion Exhibit 1010
`Page 2
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`while the laser arm had a mean decrease of -0.4dB. VTE was generally well-tolerated, and
`adverse events (AEs) reported were those typically associated with intravitreal injections or
`underlying disease. There were two cases of endophthalmitis, one culture negative and
`one positive for Staphylococcus epidermidis. The most frequent AEs reported in the VTE
`arm include conjunctival hemorrhage, eye pain, oaters, ocular hyperemia, and increased
`IOP.
`Conclusions: : In this patient population at the 24-week primary endpoint, intravitreal VTE
`was generally well tolerated and produced signi cant improvements from baseline in
`visual acuity and retinal thickness and a trend toward improvement in central retinal
`sensitivity as compared to laser photocoagulation.
`Clinical Trial: : www.clinicaltrials.gov NCT00789477
`Keywords: diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention
`assessment/controlled clinical trials • vascular endothelial growth factor
`© 2010, 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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