Visual prosthetic device effective for end-stage AMD

MONTREAL — An implantable visual prosthesis is “effective in improving both distance and near visual acuity in patients with advanced, end-stage macular degeneration,” said Henry L. Hudson, MD, FACS, speaking on results of a phase 2/3 trial.

The trial enrolled 206 patients at least 55 years old with vision ranging from 20/80 to 20/800 who had monocular implantation of the IMT002 visual prosthesis in the worse eye. Safety was based on endothelial cell density and preservation of vision, with a primary endpoint of having 50% of the patients achieve at least two lines of improvement in either distance or near vision, Dr. Hudson said.

“The VA endpoint was met in 90% of the patients who gained two lines or greater in near or distance vision,” he told attendees here at the American Society of Retina Specialists meeting. In addition, preservation of vision was met, and endothelial cell density dropped by 25%.

At 1 year, mean distance best corrected visual acuity improved from 20/316 to 20/141. Mean near BCVA improved from 20/156 to 20/89 at 8 inches and from 20/240 to 20/146 at 16 inches.

Adverse events included two choroidal hemorrhages, and one device dropped into the vitreous. Postoperatively, one patient developed a wet membrane that was successfully treated by laser photocoagulation. No retinal detachments were reported.