drugset / Trial / NCT00320775
Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
Timeline
- Start
- 2005-06
- Primary completion
- 2008-06
- Completion
- 2008-08
Publications
- Results Nguyen QD, Campochiaro PA, Shah SM, Browning DJ, Hudson HL, Sonkin PL, Hariprasad SM, Kaiser PK, Slakter J, Haller JA, Do DV, Mieler W, Chu K, Ingerman A, Vitti R, Berliner AJ, Cedarbaum J; Clear-It 1 Investigators. Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. J Ocul Pharmacol Ther. 2012 Dec;28(6):581-8. doi: 10.1089/jop.2011.0261. Epub 2012 Jul 9.
- Results Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ, Vitti R, Ruckert R, Sandbrink R, Stein D, Yang K, Beckmann K, Heier JS. The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema. Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 0.05 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 0.15 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 0.5 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 1 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 4 mg | Intravitreal |