Journal article
RNAi-Based Treatment for Neovascular Age-Related Macular Degeneration by Sirna-027
PK Kaiser, RCA Symons, SM Shah, EJ Quinlan, H Tabandeh, DV Do, G Reisen, JA Lockridge, B Short, R Guerciolini, QD Nguyen
American Journal of Ophthalmology | Published : 2010
Abstract
Purpose: To assess the safety, tolerability, pharmacokinetics, and dose-limiting toxicity of single intravitreal injection of Sirna-027, a small interfering RNA targeting vascular endothelial growth factor receptor-1, in patients with choroidal neovascularization (CNV) resulting from neovascular age-related macular degeneration (AMD). Secondary objectives included assessment of anatomic changes in retinal thickness, size of CNV, and changes in visual acuity. Design: Prospective, open-label, single-dose, dose-escalation phase 1 study. Methods: Twenty-six eyes of 26 patients with a median age of 82 years and CNV resulting from AMD who had previous treatments with other therapies were treated a..
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Funding Acknowledgements
SUPPORTED BY SIRNA THERAPEUTICS, INC, SAN FRANCISO, CALIFORNIA. THE COLE EYE INSTITUTE, THE EMPLOYER OF DR Kaiser, and the Johns Hopkins University, the employer of Drs Symons, Shah, Quinlan, Do, and Nguyen, have received research grant support from Allergan and Sirna Therapeutics, Inc. Drs Kaiser and Quinlan served on the Scientific Advisory Board of Allergan. Drs Lockridge and Guerciolini and Ms Reisen were employees of Sirna Therapeutics, Inc. Dr Short is an employee of Allergan, Inc. Involved in design and conduct of the study (P.K.K., R.G., Q.D.N.); Collection, management, analysis, and interpretation of the data (P.K.K., R.C.A.S., S.M.S., E.J.Q., H.T., D.V.D., OR., J.A.L., B.S., R.G., Q.D.N.); and Preparation, review, or approval of the manuscript (P.K.K., S.M.S., E.J.Q., H.T., D.V.D., OR., J.A.L., B.S., R.G., Q.D.N.). The study received institutional review board approval at both the Wilmer Eye Institute, Johns Hopkins University, and the Cole Eye Institute, Cleveland Clinics. All study sites were compliant with the Health Insurance Portability and Accountability Act of 1996. Before determination of eligibility for enrollment, patients provided written, informed consent for study participation. The study was posted to http://www.clinicaltrials.gov (identified no. NCT00363714).