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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
High Dose NT-501
Low Dose NT-501
Sham Procedure
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Group of Florida
Hollywood, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Beaumont Eye Institute
Royal Oak, Michigan, 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
BCVA Response Defined as an Increased in 10 Letters at 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.
Time frame: 1 year post-implant
The Change in BCVA Over the 18-month Follow-up Period
Change from baseline at post-baseline visits in monocular best visual acuity (BCVA) as assessed by standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Time frame: From initial implant 18 months post-implant
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