Intravitreal AdPEDF demonstrates favorable safety, efficacy potential

February 21, 2006

Favorable Phase I study results have led to the launch of a Phase I/II trial evaluating the efficacy and safety of AdPEDF (GenVec) treatment of exudative AMD, said Timothy Stout, MD, at the World Ophthalmology Congress.

Favorable Phase I study results have led to the launch of a Phase I/II trial evaluating the efficacy and safety of AdPEDF (GenVec) treatment of exudative AMD, said Timothy Stout, MD, at the World Ophthalmology Congress.

AdPEDF is a second-generation adenovector expressing the human pigment epithelium-derived factor (PEDF) gene. In the dose-escalation Phase I trial, 28 patients received a single intravitreal injection of AdPEDF over the dose range of 1 x 106 pu to 1 x 109.5 pu. Eligible patients had severe neovascularization with BCVA of 20/200 or worse, leaking subfoveal choroidal neovascular lesions up to 12 disc areas in size, and were considered as not suitable candidates for other treatments.

The results showed AdPEDF was well tolerated up to the maximum dose tested and did not result in any drug-related serious adverse events, dose-limiting toxicity or endophthalmitis. Mild anterior chamber flare and cells were the most common adverse events related to the treatment but were not dose-related.

"Little can be said about the efficacy of this study as it was not powered to evaluate efficacy endpoints and considering these patients had such advanced disease. However, we did observe changes in visual acuity and retinal appearance at the higher dose that are very encouraging," said Dr. Stout of the Casey Eye Institute/University of Oregon in the United States.