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)

July 14, 2022 updated by: Neurotech Pharmaceuticals

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beer Sheva, Israel
        • Soroka Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah-Hebrew University Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petach-tikva, Israel, 49100
        • Rabin Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel-Aviv, Israel, 64239
        • Sourasky Medical Center,
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants, Ltd.
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Irvine, California, United States, 92697
        • University of California, Irvine, The Gavin Herbert Eye Institute
      • La Jolla, California, United States, 92093
        • Jacobs Retina Center at UCSD
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center, PC
      • Marietta, Georgia, United States, 30060
        • Georgina Retina, P.C.
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Illinois Retina Associates, S.C.
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan, Kellogg Eye Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Ophthalmology Research
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey, LLC
      • New Brunswick, New Jersey, United States, 08901
        • NJ Retina
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Eye Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97210
        • Retina Northwest, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center, LLC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Active Comparator: Eylea® injected intravitreally 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Charles Johnson, MB, ChB, Neurotech Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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