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

NCT00447954 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-03-28

Study results available
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Summary

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.

Conditions

  • Nonexudative Age-Related Macular Degeneration, Unspecified Eye, Intermediate Dry Stage

Interventions

COMBINATION_PRODUCT

High Dose NT-501 implant

High Dose NT-501

COMBINATION_PRODUCT

Low Dose NT-501 implant

Low Dose NT-501

OTHER

Sham

Sham Procedure

Sponsors & Collaborators

  • Neurotech Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Weng Tao, M.D., PhD · Neurotech Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-05
Primary Completion
2009-05-11
Completion
2009-05-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447954 on ClinicalTrials.gov