drugset / Trial / NCT00447954

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

NCT00447954 ↗

Phase 2 Completed 53 enrolled Neurotech Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-01-05
Primary completion
2009-05-11
Completion
2009-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciliary neurotrophic factor Cell therapy 5 ng Other
Subject Ciliary neurotrophic factor Cell therapy 20 ng Other