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)

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 38 Study Locations

Sponsors and Collaborators

Neurotech Pharmaceuticals

Investigators

Study Chair:	Charles Johnson, MB, ChB	Neurotech Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02228304 History of Changes
Other Study ID Numbers:	NT-503-3-AMD-001
First Posted:	August 29, 2014
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:

Macular Degeneration; Choroidal Neovascularization; Retinal Degeneration; Retinal Diseases; Eye Diseases	Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes