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

• The mean, median, and distribution of change in BCVA over the 18-month follow-up period [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• change in ERG between baseline and months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
• change in area of geographic atrophy from baseline to months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
• change in area of drusen from baseline to months 12 and 18 [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
• change in retinal thickness from baseline to months 12 and 18 measured by OCT [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
• and change in quality of life between baseline and months 12 and 18 using NEI-VFQ25. [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]

• The mean, median, and distribution of change in BCVA over the 18-month follow-up period
• change in ERG between baseline and months 12 and 18
• change in area of geographic atrophy from baseline to months 12 and 18
• change in area of drusen from baseline to months 12 and 18
• change in retinal thickness from baseline to months 12 and 18 measured by OCT
• and change in quality of life between baseline and months 12 and 18 using NEI-VFQ25.

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.

The study will involve about 18 visits over 1½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visits for the surgical procedures. There will be about 8 centers participating in this study, and up to 48 people enrolled, across the US. Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on one eye, which may or may not include a very small cell-filled implant. Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat AMD.

• Drug: NT-501 implant
  High Dose
• Drug: NT-501 implant
  Low Dose
• Other: Sham Procedure
  Sham Procedure

• Experimental: 1 high dose NT-501 implant
  Intervention: Drug: NT-501 implant
• Experimental: 2 low dose NT-501 implant
  Intervention: Drug: NT-501 implant
• Sham Comparator: 3 sham procedure
  No implant
  Intervention: Other: Sham Procedure

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.