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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurotech Pharmaceuticals

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.