Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.

Clinical Hypotheses:

• NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD

• NT-503-3 ECT has an acceptable safety profile

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurotech Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye

• Prior Intravitreal Anti-VEGF injections

Key Exclusion Criteria:

• Significant subretinal hemorrhage

• Significant Scar and/or, fibrosis

• Suspected polypoidal choroidopathy, or pigment epithelial tears or rips

• Inadequate response to anti-VEGF therapy