The da VINCI study: Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema

Diana V. Do, Ursula Schmidt-Erfurth, Victor H. Gonzalez, Carmelina M. Gordon, Michael Tolentino, Alyson J. Berliner, Robert Vitti, Rene Rückert, Rupert Sandbrink, David Stein, Ke Yang, Karola Beckmann, Jeff S. Heier

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Abstract

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). Design: Multicenter, randomized, double-masked, phase 2 clinical 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 VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter. 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 ≤ 0.0085 for each VEGF Trap-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 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. 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 produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

Original languageEnglish (US)
Pages (from-to)1819-1826
Number of pages8
JournalOphthalmology
Volume118
Issue number9
DOIs
StatePublished - Sep 1 2011

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Macular Edema
Vascular Endothelial Growth Factor A
Lasers
Light Coagulation
Visual Acuity
Disclosure
Diabetic Retinopathy

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Do, D. V., Schmidt-Erfurth, U., Gonzalez, V. H., Gordon, C. M., Tolentino, M., Berliner, A. J., ... Heier, J. S. (2011). The da VINCI study: Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema. Ophthalmology, 118(9), 1819-1826. https://doi.org/10.1016/j.ophtha.2011.02.018

The da VINCI study : Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema. / Do, Diana V.; Schmidt-Erfurth, Ursula; Gonzalez, Victor H.; Gordon, Carmelina M.; Tolentino, Michael; Berliner, Alyson J.; Vitti, Robert; Rückert, Rene; Sandbrink, Rupert; Stein, David; Yang, Ke; Beckmann, Karola; Heier, Jeff S.

In: Ophthalmology, Vol. 118, No. 9, 01.09.2011, p. 1819-1826.

Research output: Contribution to journalArticle

Do, DV, Schmidt-Erfurth, U, Gonzalez, VH, Gordon, CM, Tolentino, M, Berliner, AJ, Vitti, R, Rückert, R, Sandbrink, R, Stein, D, Yang, K, Beckmann, K & Heier, JS 2011, 'The da VINCI study: Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema', Ophthalmology, vol. 118, no. 9, pp. 1819-1826. https://doi.org/10.1016/j.ophtha.2011.02.018
Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ et al. The da VINCI study: Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema. Ophthalmology. 2011 Sep 1;118(9):1819-1826. https://doi.org/10.1016/j.ophtha.2011.02.018
Do, Diana V. ; Schmidt-Erfurth, Ursula ; Gonzalez, Victor H. ; Gordon, Carmelina M. ; Tolentino, Michael ; Berliner, Alyson J. ; Vitti, Robert ; Rückert, Rene ; Sandbrink, Rupert ; Stein, David ; Yang, Ke ; Beckmann, Karola ; Heier, Jeff S. / The da VINCI study : Phase 2 primary results of VEGF trap-eye in patients with diabetic macular edema. In: Ophthalmology. 2011 ; Vol. 118, No. 9. pp. 1819-1826.
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abstract = "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). Design: Multicenter, randomized, double-masked, phase 2 clinical 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 VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter. 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 ≤ 0.0085 for each VEGF Trap-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 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. 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 produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.",
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AU - Tolentino, Michael

AU - Berliner, Alyson J.

AU - Vitti, Robert

AU - Rückert, Rene

AU - Sandbrink, Rupert

AU - Stein, David

AU - Yang, Ke

AU - Beckmann, Karola

AU - Heier, Jeff S.

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N2 - 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). Design: Multicenter, randomized, double-masked, phase 2 clinical 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 VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter. 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 ≤ 0.0085 for each VEGF Trap-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 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. 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 produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

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