Intravitreal AdPEDF demonstrates favorable safety, efficacy potential

Article

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.

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Christine Curcio, PhD, of the University of Alabama at Birmingham Heersink School of Medicine, shares histology update and revised nomenclature for OCT with Sheryl Stevenson of the Eye Care Network and Ophthalmology Times
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.
Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium. In conversation with Hattie Hayes, Ophthalmology Times Europe
Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe
Tyson Brunstetter, OD, PhD, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, shares key takeaways from his keynote at the International SPECTRALIS Symposium (ISS)
Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium
At the Retina World Congress, Siegfried Priglinger, MD, speaks about ensuring the best outcomes for preschool-aged patients
At the 2025 ASCRS meeting, Robert Ang, MD said small aperture IOLs can benefit all patients, especially those with complex corneas or who have undergone previous corneal refractive surgery
© 2025 MJH Life Sciences

All rights reserved.