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P. Campochiaro, M. Klein, E. Holz, A. Gupta, D. Saperstein, S. Bressler, L.L. Wei, A. Ray, R.N. Frank, T. Stout; AdPEDF Therapy for Subfoveal Choroidal Neovascularization (CNV): Preliminary Phase I Results . Invest. Ophthalmol. Vis. Sci. 2004;45(13):2361.
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Purpose: To evaluate the safety and feasibility of intravitreous AdPEDF in patients with subfoveal CNV due to age–related macular degeneration (AMD). Methods: Open label, dose–escalation design with 8 dose levels (106–109.5 pu in ½ log increments) in patients with subfoveal CNV ≤ 12 MPS disc areas and best corrected visual acuity of 20/200 or worse in study eye. After a single intravitreous injection of AdPEDF, 1 year follow–up consisted of periodic ocular exams, fluorescein angiograms, and laboratory evaluations including adenovirus neutralizing antibody titers and throat and urine cultures for adenovirus. Optical Coherence Tomography was performed as a substudy at 2 study sites. Results: Six of 8 dose cohorts have been fully enrolled (n=18), and accrual is ongoing. Intravitreous AdPEDF has been well–tolerated and there have been no dose limiting toxicities or related severe adverse events. Three patients (two at 107.5 and one at 108.5 pu) had mild transient inflammation and Grade 1 elevation in IOP thought to be probably or possibly related to the study drug. Neutralizing antibody titers did not increase at 3 months in 11 out of 12 patients and all adenoviral cultures were negative. Conclusions: Intravitreous injection of up to 108.5 pu of AdPEDF is well–tolerated and has not been associated with any serious short–term toxicity.
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