A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00447954
First received: March 9, 2007
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in participants with atrophic macular degeneration. This research is being done because there are no effective therapies for people with atrophic macular degeneration. Age-related macular degeneration (AMD) is a condition that affects the macula, the central part of the retina that we use for seeing details. There are two types of AMD, one is the wet type in which new blood vessels grow, also known as choroidal neovascularization (CNV), but the other is the dry type in which the healthy cells die, and that is the target of this study. This is called atrophic macular degeneration. The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose, as well as a sham surgery (or placebo) group.


Condition Intervention Phase
Macular Degeneration
Drug: NT-501 implant
Other: Sham Procedure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF), in Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Neurotech Pharmaceuticals:

Primary Outcome Measures:
  • The increase in best-corrected visual acuity (BCVA) using the Electronic Visual Acuity (EVA) technology from baseline to 1 year. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean, median, and distribution of change in BCVA over the 18-month follow-up period [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • change in ERG between baseline and months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • change in area of geographic atrophy from baseline to months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • change in area of drusen from baseline to months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • change in retinal thickness from baseline to months 12 and 18 measured by OCT [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • and change in quality of life between baseline and months 12 and 18 using NEI-VFQ25. [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 high dose NT-501 implant Drug: NT-501 implant
High Dose
Experimental: 2 low dose NT-501 implant Drug: NT-501 implant
Low Dose
Sham Comparator: 3 sham procedure
No implant
Other: Sham Procedure
Sham Procedure

Detailed Description:

The study will involve about 18 visits over 1½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visits for the surgical procedures. There will be about 8 centers participating in this study, and up to 48 people enrolled, across the US. Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on one eye, which may or may not include a very small cell-filled implant. Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat AMD.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Study inclusion / exclusion criteria:

Criteria for patients to qualify for the study include, but are not limited to:

  • Participants must be at least 50 years old
  • Diagnosis of age-related macular degeneration with the presence of geographic atrophy
  • Visual acuity no better than 20/63 and no worse than 20/160
  • History of recent visual acuity loss

The following criteria will exclude patients from the study:

  • Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception.
  • Age-related macular degeneration with new blood vessel growth
  • Other eye diseases including advanced cataract.
  • Chronic systemic disease requiring continuous treatment with systemic steroids, immunosuppressive medications or insulin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447954

Locations
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Florida
Retina Group of Florida
Hollywood, Florida, United States, 33021-6746
Bascom Palmer Eye Institute
Miami, Florida, United States, 33101
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
Beaumont Eye Institute
Royal Oaks, Michigan, United States, 48073-6710
United States, Texas
Retina Foundation of Southwest
Dallas, Texas, United States, 75231
Vitreoretinal Consultants
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
Study Director: Weng Tao, M.D., PhD Neurotech Pharmaceuticals
  More Information

Additional Information:
No publications provided by Neurotech Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weng Tao, MD, PhD, Neurotech USA
ClinicalTrials.gov Identifier: NCT00447954     History of Changes
Obsolete Identifiers: NCT00277134
Other Study ID Numbers: CNTF 2
Study First Received: March 9, 2007
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurotech Pharmaceuticals:
eye disease
retinal disorder
CNTF

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014