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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)

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NT-503-3 ECT implantation
Eylea® injected intravitreally administered every 8 weeks
Sponsored by
Neurotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Associated Retina Consultants, Ltd.
  • Retina-Vitreous Associates Medical Group
  • University of California, Irvine, The Gavin Herbert Eye Institute
  • Jacobs Retina Center at UCSD
  • Colorado Retina Associates
  • Retina Health Center
  • National Ophthalmic Research Institute
  • Center for Retina and Macular Disease
  • Southeast Retina Center, PC
  • Georgina Retina, P.C.
  • Illinois Retina Associates, S.C.
  • Illinois Retina Associates
  • Retina Associates of Kentucky
  • The Retina Group of Washington
  • Cumberland Valley Retina Consultants, PC
  • Ophthalmic Consultants of Boston
  • University of Michigan, Kellogg Eye Center
  • William Beaumont Hospital-Ophthalmology Research
  • Lifelong Vision Foundation
  • Sierra Eye Associates
  • Retina Center of New Jersey, LLC
  • NJ Retina
  • Western Carolina Retinal Associates
  • Wake Forest Baptist Health Eye Center
  • Cleveland Clinic
  • Retina Northwest, PC
  • Mid Atlantic Retina
  • Palmetto Retina Center, LLC
  • Black Hills Regional Eye Institute
  • Valley Retina Institute, PA
  • Medical Center Ophthalmology Associates
  • Medical College of Wisconsin
  • Soroka Medical Center
  • Hadassah-Hebrew University Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Kaplan Medical Center
  • Sourasky Medical Center,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NT-503-3 ECT implantation

Eylea® injected intravitreally every 8 weeks

Arm Description

Eylea® injected intravitreally every 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2014
Last Updated
July 14, 2022
Sponsor
Neurotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02228304
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotech Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NT-503-3 ECT implantation
Arm Type
Experimental
Arm Title
Eylea® injected intravitreally every 8 weeks
Arm Type
Active Comparator
Arm Description
Eylea® injected intravitreally every 8 weeks
Intervention Type
Drug
Intervention Name(s)
NT-503-3 ECT implantation
Intervention Description
NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
Intervention Type
Drug
Intervention Name(s)
Eylea® injected intravitreally administered every 8 weeks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
Time Frame
Week 52 and Week 108
Secondary Outcome Measure Information:
Title
Change from baseline in best corrected visual acuity (BCVA)
Time Frame
Week 52
Title
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
Time Frame
Up to Week 108
Title
Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
Time Frame
Up to Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Johnson, MB, ChB
Organizational Affiliation
Neurotech Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California, Irvine, The Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Jacobs Retina Center at UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgina Retina, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Retina Associates, S.C.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Illinois Retina Associates
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Cumberland Valley Retina Consultants, PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
William Beaumont Hospital-Ophthalmology Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Center of New Jersey, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
NJ Retina
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Wake Forest Baptist Health Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Retina Center, LLC
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sourasky Medical Center,
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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)

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