Neurotech Pharmaceuticals, Inc. has announced that they have enrolled the first patient in their multicenter Phase 2 clinical trial of NT-503 Encapsulated Cell Therapy (ECT) for the long-term treatment of wet macular degeneration (AMD). NT-503 is a unique vascular endothelial growth factor (VEGF) receptor protein continuously produced by Neurotech’s versatile ECT implant.
“This landmark proof-of-concept study will evaluate NT-503 ECT as a viable alternative to frequent intravitreal injections in wet AMD patients,” said Charles Johnson, MD, Chief Medical Officer. “We believe NT-503 ECT has the potential to maintain visual acuity in patients who have already exhibited a good response to intravitreal injections, while reducing the long-term treatment burden. This program will provide key information regarding the safety and efficacy of NT-503 ECT as we continue to make progress toward our goal of advancing treatment for wet AMD and other chronic posterior segment conditions.”
The Phase 2 randomized, active-controlled, masked study will evaluate the safety and efficacy of NT-503 ECT compared to aflibercept (Eylea®) intravitreal injections. Approximately 150 patients who have previously been treated with at least 3 anti-VEGF injections and have demonstrated a good clinical response will be enrolled. This study will compare maintenance of vision in patients randomized to receive a single NT-503 ECT implant or aflibercept injections every 8 weeks. Efficacy will be evaluated using a combination of endpoints including: change in visual acuity, change in retinal thickness, rate of treatment failures, and rate of rescue medication. A primary analysis will be conducted at one year and patients will be followed for two years.
Arshad Khanani, MD, Managing Partner of Sierra Eye Associates in Reno, Nevada, is the first retinal surgeon to enroll a patient in the trial. “ECT represents the future of drug delivery,” said Dr. Khanani. “It has the capability to allow for the continuous delivery of therapeutics with a single surgical procedure.”
Neurotech anticipates enrollment to be completed by the end of 2015 and plans to report top-line data from their Phase 2 program in the first half of 2017. More information about ECT.
Source: Neurotech Pharmaceuticals, Inc.