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)

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02228304

Enrollment

Registered

2014-08-29

Start date

2014-09-30

Completion date

2016-04-30

Last updated

2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV

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

Interventions

DRUGNT-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

DRUGEylea® 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026