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

Sponsor

Neurotech Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00447954

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: NT-501 implant Drug: NT-501 implant Other: Sham Procedure	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF), in Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 high dose NT-501 implant	Drug: NT-501 implant High Dose
Experimental: 2 low dose NT-501 implant	Drug: NT-501 implant Low Dose
Sham Comparator: 3 sham procedure No implant	Other: Sham Procedure Sham Procedure

Arm

Intervention/Treatment

Experimental: 1 high dose NT-501 implant

Drug: NT-501 implant

High Dose

Experimental: 2 low dose NT-501 implant

Drug: NT-501 implant

Low Dose

Sham Comparator: 3 sham procedure

No implant

Other: Sham Procedure

Sham Procedure

Outcome Measures

Primary Outcome Measures

The increase in best-corrected visual acuity (BCVA) using the Electronic Visual Acuity (EVA) technology from baseline to 1 year. [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina-Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
2	Retina Group of Florida	Hollywood	Florida	United States	33021-6746
3	Bascom Palmer Eye Institute	Miami	Florida	United States	33101
4	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
5	Beaumont Eye Institute	Royal Oaks	Michigan	United States	48073-6710
6	Retina Foundation of Southwest	Dallas	Texas	United States	75231
7	Vitreoretinal Consultants	Houston	Texas	United States	77030
8	University of Utah	Salt Lake City	Utah	United States	84132