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)

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228304
• Other study ID #: NT-503-3-AMD-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2022
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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
• 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.

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheva
Israel	Hadassah-Hebrew University Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach-tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Sourasky Medical Center,	Tel-Aviv
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	Southeast Retina Center, PC	Augusta	Georgia
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Retina Center of New Jersey, LLC	Bloomfield	New Jersey
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	The Retina Group of Washington	Chevy Chase	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Palmetto Retina Center, LLC	Florence	South Carolina
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Health Center	Fort Myers	Florida
United States	Colorado Retina Associates	Golden	Colorado
United States	Cumberland Valley Retina Consultants, PC	Hagerstown	Maryland
United States	University of California, Irvine, The Gavin Herbert Eye Institute	Irvine	California
United States	Illinois Retina Associates, S.C.	Joliet	Illinois
United States	Jacobs Retina Center at UCSD	La Jolla	California
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Georgina Retina, P.C.	Marietta	Georgia
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	NJ Retina	New Brunswick	New Jersey
United States	Illinois Retina Associates	Oak Park	Illinois
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Associated Retina Consultants, Ltd.	Phoenix	Arizona
United States	Retina Northwest, PC	Portland	Oregon
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	William Beaumont Hospital-Ophthalmology Research	Royal Oak	Michigan
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Wake Forest Baptist Health Eye Center	Winston-Salem	North Carolina
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters		Week 52 and Week 108
Secondary	Change from baseline in best corrected visual acuity (BCVA)		Week 52
Secondary	Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)		Up to Week 108
Secondary	Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy		Up to Week 108