A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
- Conditions
- Nonexudative Age-Related Macular Degeneration, Unspecified Eye, Intermediate Dry Stage
- Interventions
- Other: Sham Procedure
- Registration Number
- NCT00447954
- Lead Sponsor
- Neurotech Pharmaceuticals
- Brief 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.
- Detailed Description
Histopathologic studies of multiple forms of retinal neurodegenerative diseases have demonstrated the possibility of using the neurotrophic factor CNTF as an effective approach to reducing photoreceptor cell loss. Consequently, it had been hypothesized that the use of the implanted NT-501 capsule, which secretes CNTF into the vitreous, might be beneficial in people with atrophic macular degeneration. The purpose of this pilot study was to accumulate preliminary data on the effect of the intraocular NT-501 implant on visual acuity in patients with atrophic macular degeneration.
The study had a double-masked, multi-center, randomized, parallel group design. Eligible patients were randomized on a 2:1:1 basis to the higher CNTF output NTC-201-6A.02 implant, the lower CNTF output NTC-201-10.02 implant or to sham surgery, respectively.
The surgeon designated by the Principal Investigator (PI), the PI, vision examiners, reading center graders, and patients were all masked as to the dose of the implant. The patients and the vision examiners were masked as to which treatment was received.
Approximately 48 patients with geographic atrophy compatible with category 3 or 4 AMD were planned to be enrolled. All patients were to be followed clinically for 18 months. Patients randomized to the CNTF implants were implanted at baseline, had the option of being explanted at or after 12 months, and all were followed clinically for 18 months. Follow-up for safety occurred throughout the study period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 high dose NT-501 implant NT-501 implant - 3 sham procedure Sham Procedure No implant 2 low dose NT-501 implant NT-501 implant -
- Primary Outcome Measures
Name Time Method BCVA Response Defined as an Increased in 10 Letters at 1 Year Post-implant 1 year post-implant Response is defined as a improvement from baseline at Month 12 in monocular best visual acuity (BCVA) in the study eye of at least 10 letters as assessed by standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
- Secondary Outcome Measures
Name Time Method The Change in BCVA Over the 18-month Follow-up Period From initial implant 18 months post-implant Change from baseline at post-baseline visits in monocular best visual acuity (BCVA) as assessed by standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Trial Locations
- Locations (16)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Beaumont Eye Institute
🇺🇸Royal Oaks, Michigan, United States
Retina Group of Florida
🇺🇸Hollywood, Florida, United States
Vitreoretinal Consultants
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Retina Foundation of Southwest
🇺🇸Dallas, Texas, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Foundation of Southwest
🇺🇸Dallas, Texas, United States
Vitreoretinal Consultants
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Retina Group of Florida
🇺🇸Hollywood, Florida, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Beaumont Eye Institute
🇺🇸Royal Oak, Michigan, United States