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)

NCT ID: NCT02228304

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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NT-503-3 ECT implantation

Group Type EXPERIMENTAL

NT-503-3 ECT implantation

Intervention Type DRUG

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 every 8 weeks

Eylea® injected intravitreally every 8 weeks

Group Type ACTIVE_COMPARATOR

Eylea® injected intravitreally administered every 8 weeks

Intervention Type 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.

Interventions

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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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurotech Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Johnson, MB, ChB

Role: STUDY_CHAIR

Neurotech Pharmaceuticals, Inc.

Locations

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Associated Retina Consultants, Ltd.

Phoenix, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

University of California, Irvine, The Gavin Herbert Eye Institute

Irvine, California, United States

Site Status

Jacobs Retina Center at UCSD

La Jolla, California, United States

Site Status

Colorado Retina Associates

Golden, Colorado, United States

Site Status

Retina Health Center

Fort Myers, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status

Southeast Retina Center, PC

Augusta, Georgia, United States

Site Status

Georgina Retina, P.C.

Marietta, Georgia, United States

Site Status

Illinois Retina Associates, S.C.

Joliet, Illinois, United States

Site Status

Illinois Retina Associates

Oak Park, Illinois, United States

Site Status

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status

The Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Consultants, PC

Hagerstown, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Site Status

William Beaumont Hospital-Ophthalmology Research

Royal Oak, Michigan, United States

Site Status

Lifelong Vision Foundation

Chesterfield, Missouri, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Retina Center of New Jersey, LLC

Bloomfield, New Jersey, United States

Site Status

NJ Retina

New Brunswick, New Jersey, United States

Site Status

Western Carolina Retinal Associates

Asheville, North Carolina, United States

Site Status

Wake Forest Baptist Health Eye Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Retina Northwest, PC

Portland, Oregon, United States

Site Status

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Site Status

Palmetto Retina Center, LLC

Florence, South Carolina, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Valley Retina Institute, PA

McAllen, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Sourasky Medical Center,

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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NT-503-3-AMD-001

Identifier Type: -

Identifier Source: org_study_id

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