Neurotech Treatment Shows Biological Effect in RP Clinical Studies

Investigators reported that treated retinas were thicker, and therefore likely healthier, than those untreated, and the amount of thickening was dose dependent; the higher dose treatment appeared to result in greater thickening. Increased retinal thickening had not translated into better visual acuities or broader visual fields at the 12-month points in the studies.

One trial is an18-month investigation for people with late-stage retinal degeneration. The other study, which enrolled people with early-stage retinal degeneration, is a 30-month trial. Investigators will continue to monitor and report results as these trials move forward.

“These results are encouraging, because they are biologically significant and consistent. Treated retinas do appear to be healthier,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “We hope to see the biological benefit lead to a visual benefit as these studies progress. Vision loss for many people with retinal degenerative diseases occurs over several decades, so we may need more time to identify a trend in vision improvement.”

In March 2009, Neurotech reported that the high-dose ECT treatment preserved vision in 96.3 percent of participants with Geographic Atrophy (late-stage dry age-related macular degeneration) participating in a 12-month Phase II clinical study. People with better visual acuity at the start of the treatment — 20/63 or better — appeared to benefit most. The company is currently working toward a Phase III study of the ECT for people with Geographic Atrophy.

“We are pleased with the potential that Neurotech’s treatment is showing for preserving vision in people affected by a broad range of retinal degenerative diseases,” says William T. Schmidt, chief executive officer, Foundation Fighting Blindness. “Currently, there are virtually no other treatment options for these people. We look forward to hearing more results from the Neurotech studies as they move forward.”

The ECT implant is a tiny device — the size of a grain of rice — that contains cells which provide sustained delivery of a vision-preserving protein known as ciliary neurotrophic factor.

In addition to funding the clinical trials of the ECT for RP and related diseases, the Foundation Fighting Blindness funded the pivotal laboratory research that made all of the current human studies possible.