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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)

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ClinicalTrials.gov Identifier: NCT02228304
Recruitment Status : Terminated
First Posted : August 29, 2014
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: NT-503-3 ECT implantation Drug: Eylea® injected intravitreally administered every 8 weeks Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NT-503-3 ECT implantation 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
Active Comparator: Eylea® injected intravitreally every 8 weeks
Eylea® injected intravitreally every 8 weeks
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters [ Time Frame: Week 52 and Week 108 ]

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

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228304


Locations
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Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
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Study Chair: Charles Johnson, MB, ChB Neurotech Pharmaceuticals, Inc.
More Information
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Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02228304    
Other Study ID Numbers: NT-503-3-AMD-001
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Keywords provided by Neurotech Pharmaceuticals:
Wet AMD
Wet Age Related Macular Degeneration
Recurrent CNV Secondary to AMD
Active subfoveal CNV
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases