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)

Overview

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

Full Title of Study: “A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: NT-503-3 ECT implantation
    • NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
  • Drug: Eylea® injected intravitreally administered every 8 weeks
    • The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.

Arms, Groups and Cohorts

  • Experimental: NT-503-3 ECT implantation
  • Active Comparator: Eylea® injected intravitreally every 8 weeks
    • Eylea® injected intravitreally every 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
    • Time Frame: Week 52 and Week 108

Secondary Measures

  • Change from baseline in best corrected visual acuity (BCVA)
    • Time Frame: Week 52
  • Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
    • Time Frame: Up to Week 108
  • Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
    • Time Frame: Up to Week 108

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neurotech Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles Johnson, MB, ChB, Study Chair, Neurotech Pharmaceuticals, Inc.

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