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)

Phase 1

Terminated

• Conditions: Macular Degeneration
• Interventions: Drug: NT-503-3 ECT implantation; Drug: Eylea® injected intravitreally administered every 8 weeks

• Registration Number: NCT02228304
• Lead Sponsor: Neurotech Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-08-29
• Study Start: 2014-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Disposition First Submitted: 2016-11-15
• Disposition First Submitted QC: 2016-11-15
• Disposition First Posted: 2016-11-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NT-503-3 ECT implantation	NT-503-3 ECT implantation	-
Eylea® injected intravitreally every 8 weeks	Eylea® injected intravitreally administered every 8 weeks	Eylea® injected intravitreally every 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (38)

Associated Retina Consultants, Ltd.; 🇺🇸 Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

University of California, Irvine, The Gavin Herbert Eye Institute; 🇺🇸 Irvine, California, United States

Jacobs Retina Center at UCSD; 🇺🇸 La Jolla, California, United States

Colorado Retina Associates; 🇺🇸 Golden, Colorado, United States

Retina Health Center; 🇺🇸 Fort Myers, Florida, United States

National Ophthalmic Research Institute; 🇺🇸 Fort Myers, Florida, United States

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

Southeast Retina Center, PC; 🇺🇸 Augusta, Georgia, United States

Georgina Retina, P.C.; 🇺🇸 Marietta, Georgia, United States

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