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)

NCT02228304 | Terminated Phase 1 DMC

• 1 other identifier: NT-503-3-AMD-001
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 38

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

Conditions

Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters

  Week 52 and Week 108

Secondary Outcomes (3)

• 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

Study Arms (2)

NT-503-3 ECT implantation

EXPERIMENTAL

Drug: NT-503-3 ECT implantation

Eylea® injected intravitreally every 8 weeks

ACTIVE COMPARATOR

Eylea® injected intravitreally every 8 weeks

Drug: Eylea® injected intravitreally administered every 8 weeks

Interventions

NT-503-3 ECT implantation DRUG

NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy

NT-503-3 ECT implantation

Eylea® injected intravitreally administered every 8 weeks DRUG

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.

Eylea® injected intravitreally every 8 weeks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
• Prior Intravitreal Anti-VEGF injections

You may not qualify if:

• Significant subretinal hemorrhage
• Significant Scar and/or, fibrosis
• Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
• Inadequate response to anti-VEGF therapy

Sponsors & Collaborators

• Neurotech Pharmaceuticals: lead

Study Sites (38)

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

University of California, Irvine, The Gavin Herbert Eye Institute

Irvine, California, 92697, United States

Location

Jacobs Retina Center at UCSD

La Jolla, California, 92093, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Retina Health Center

Fort Myers, Florida, 33907, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

Georgina Retina, P.C.

Marietta, Georgia, 30060, United States

Location

Illinois Retina Associates, S.C.

Joliet, Illinois, 60435, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

The Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Cumberland Valley Retina Consultants, PC

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

William Beaumont Hospital-Ophthalmology Research

Royal Oak, Michigan, 48073, United States

Location

Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Center of New Jersey, LLC

Bloomfield, New Jersey, 07003, United States

Location

NJ Retina

New Brunswick, New Jersey, 08901, United States

Location

Western Carolina Retinal Associates

Asheville, North Carolina, 28803, United States

Location

Wake Forest Baptist Health Eye Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Retina Northwest, PC

Portland, Oregon, 97210, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Palmetto Retina Center, LLC

Florence, South Carolina, 29501, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

Hadassah-Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Sourasky Medical Center,

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Charles Johnson, MB, ChB

  Neurotech Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 29, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (32); IL (6)