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)

Neurotech

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: Eylea® injected intravitreally administered every 8 weeks; Drug: NT-503-3 ECT implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02228304

NT-503-3-AMD-001

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

NT-503-3 ECT implantation

Experimental group

Treatment:

Drug: NT-503-3 ECT implantation

Eylea® injected intravitreally every 8 weeks

Active Comparator group

Description:

Eylea® injected intravitreally every 8 weeks

Treatment:

Drug: Eylea® injected intravitreally administered every 8 weeks