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`The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Paients wi h Diabetic Macular Edema - Ophthalmology
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`ORIGINAL ARTICLE
`
`rat
`
`3
`
`1
`
`The DA VINCI Study: Phase 2 Primary Results of VEGF
`Trap-Eye in Patients with Diabetic Macular Edema
`furth, MD « Victor H. LR
`Karola 1 Jeff S. Heier, MD «
`
`Suse
`
`ae
`
`ory)
`
`18
`
`=
`
`©
`3 ey
`MeMd
`
`Articleinfo
`
`Purpose
`To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor
`(VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME).
`
`spvenvitewent
`
`Design
`LinkedArticle
`
`RelatedArticles Multicenter, randomized, double-masked, phase2clinical trial.
`
`Participants
`A total of 221 diabetic patients with clinically significant macular edema involving the central macula.
`Methods
`Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF
`Trap-Eye every 4 weeks; 2 mg VEGFTrap-Eye for3initial monthly doses and then every 8 weeks; 2 mg
`VEGF Trap-Eye for3initial monthly doses and then on an as-needed (PRN)basis; or macular laser
`photocoagulation. Assessments were completed at baseline and every 4 weeksthereafter.
`Main Outcome Measures
`Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks.
`Results
`Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4
`Early Treatment of Diabetic Retinopathy Study (ETDRS)letters versus only +2.5 letters in the laser group (P
`S$ 0.0085for each VEGFTrap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were
`‘seen in up to 93%, 64%, and 34% of VEGF Trap-Eye groups versus up to 68%, 32%, and 21% in the laser
`group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from —127.3 to -194.5
`yum compared with only —67.9 umin the laser group (P = 0.0066 for each VEGF Trap-Eye groupvs.laser).
`VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye
`were generally consistent with those seen with other intravitreal anti-VEGF agents.
`Conclusions
`Intravitreal VEGF Trap-Eye producedastatistically significant and clinically relevant improvement in visual
`
`Financial Disclosure(s)
`Proprietary or commercial disclosure may be found after the references.
`
`To read this arficleinfull you will needto make a payment
`Purchase one-time access:
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`Corporate R&D Professionals: 24 hour online access
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`https://www.aaojournal.org/ar icle/SO161-6420(11)00177-1/fulltext
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`The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Paients wi h Diabetic Macular Edema - Ophthalmology
`
`aovemteewen?
`Ophthalmology ies
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`
`ORIGINAL ARTICLE
`
`rat
`
`3
`
`1
`
`The DA VINCI Study: Phase 2 Primary Results of VEGF
`Trap-Eye in Patients with Diabetic Macular Edema
`furth, MD « Victor H. LR
`Karola 1 Jeff S. Heier, MD «
`
`Suse
`
`ae
`
`ory)
`
`18
`
`=
`
`©
`3 ey
`MeMd
`
`Articleinfo
`
`Purpose
`To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor
`(VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME).
`
`spvenvitewent
`
`Design
`LinkedArticle
`
`RelatedArticles Multicenter, randomized, double-masked, phase2clinical trial.
`
`Participants
`A total of 221 diabetic patients with clinically significant macular edema involving the central macula.
`Methods
`Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF
`Trap-Eye every 4 weeks; 2 mg VEGFTrap-Eye for3initial monthly doses and then every 8 weeks; 2 mg
`VEGF Trap-Eye for3initial monthly doses and then on an as-needed (PRN)basis; or macular laser
`photocoagulation. Assessments were completed at baseline and every 4 weeksthereafter.
`Main Outcome Measures
`Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks.
`Results
`Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4
`Early Treatment of Diabetic Retinopathy Study (ETDRS)letters versus only +2.5 letters in the laser group (P
`S$ 0.0085for each VEGFTrap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were
`‘seen in up to 93%, 64%, and 34% of VEGF Trap-Eye groups versus up to 68%, 32%, and 21% in the laser
`group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from —127.3 to -194.5
`yum compared with only —67.9 umin the laser group (P = 0.0066 for each VEGF Trap-Eye groupvs.laser).
`VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye
`were generally consistent with those seen with other intravitreal anti-VEGF agents.
`Conclusions
`Intravitreal VEGF Trap-Eye producedastatistically significant and clinically relevant improvement in visual
`
`Financial Disclosure(s)
`Proprietary or commercial disclosure may be found after the references.
`
`To read this arficleinfull you will needto make a payment
`Purchase one-time access:
`eesi oe Rated eee alae)
`
`Corporate R&D Professionals: 24 hour online access
`
`‘Alreadyanoninesubscriber?Sign in
`
`> One-timeaccesspriceinfo
`
`Subscribe:
`
`Subscribe to Ophthalmology
`
`(Alreadyaprintsubscriber? Ciaimonline access
`
`https://www.aaojournal.org/ar icle/SO161-6420(11)00177-1/fulltext
`
`1/5
`
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`3/23/23, 9:34 PM
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`The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Pa ients wi h Diabetic Macular Edema - Ophthalmology
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`
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`Samsung Bioepis Exhibit 1055 - Page 2
`Biocon Exhibit 1055 - Page 2
`
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`The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Pa ients wi h Diabetic Macular Edema - Ophthalmology
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`
`3/5
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`Samsung Bioepis Exhibit 1055 - Page 3
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`
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`The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Pa ients wi h Diabetic Macular Edema - Ophthalmology
`3/23/23, 9:34 PM
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`Article info
`Publication history
`Published online: May 05, 2011
`Accepted: February 9, 2011
`Received in revised form: February 9, 2011
`Received: September 28, 2010
`Available online: May 5, 2011.
`
`Footnotes
`Manuscript no. 2010-1342.
`
`Financial Disclosure(s): The author (s) have made the following disclosure (s): Diana V. Do: Genentech
`(financial support), Regeneron Pharmaceuticals (financial support). Ursula Schmidt-Erfuth: Alcon Labs
`(consultant, lecturer), Bayer Healthcare (consultant, lecturer), Novartis (consultant, lecturer), Regeneron
`Pharmaceuticals (lecturer), Pfizer (lecturer). Victor H. Gonzalez: Pfizer (consultant, lecturer), Genentech
`(lecturer), Eyetech (consultant, lecturer), Regeneron (lecturer). Carmelina M. Gordon: Allergan (consultant),
`Regeneron Pharmaceuticals (lecturer), Novartis (consultant, lecturer). Michael Tolentino: Genentech
`(consultant, lecturer), Eyetech (consultant, lecturer), Regeneron Pharmaceuticals (consultant, lecturer).
`Alyson J. Berliner: Regeneron Pharmaceuticals (employee, equity owner). Robert Vitti: Regeneron
`Pharmaceuticals (employee, equity owner). Rene Rückert: Bayer Schering Pharma (employee). Rupert
`Sandbrink: Bayer Schering Pharma (employee). David Stein: Regeneron Pharmaceuticals (employee, equity
`owner). Ke Yang: Regeneron Pharmaceuticals (employee, equity owner). Karola Beckmann: Bayer Schering
`Pharma (employee). Jeff S. Heier: Genentech (consultant, lecturer), Regeneron Pharmaceuticals
`(consultant, lecturer), Fovea (consultant).
`
`Funding: Sponsored by Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
`
`Identification
`DOI: https://doi.org/10.1016/j.ophtha.2011.02.018
`
`Copyright
`© 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
`
`ScienceDirect
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`VEGF Trap for Macular Edema
`Ophthalmology, Vol. 119, Issue 9
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