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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: NT-503-3 ECT implantation
* Drug: Eylea® injected intravitreally administered every 8 weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT-503-3 ECT implantation<br> | Drug: NT-503-3 ECT implantation<br>* NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy<br>|
| Active Comparator: Eylea® injected intravitreally every 8 weeks<br>Eylea® injected intravitreally every 8 weeks | Drug: Eylea® injected intravitreally administered every 8 weeks<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters |  | Week 52 and Week 108 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV