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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447954
• Other study ID #: CNTF 2
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2007
• Last updated: November 15, 2016
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: November 2016
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00277134

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• NT-501 implant
High Dose
• NT-501 implant
Low Dose

Other:
• Sham Procedure
Sham Procedure

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retina Foundation of Southwest	Dallas	Texas
United States	Retina Group of Florida	Hollywood	Florida
United States	Vitreoretinal Consultants	Houston	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Beaumont Eye Institute	Royal Oaks	Michigan
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The increase in best-corrected visual acuity (BCVA) using the Electronic Visual Acuity (EVA) technology from baseline to 1 year.		12 months	No
Secondary	The mean, median, and distribution of change in BCVA over the 18-month follow-up period		18 months	No
Secondary	change in ERG between baseline and months 12 and 18		12 and 18 months	No
Secondary	change in area of geographic atrophy from baseline to months 12 and 18		12 and 18 months	No
Secondary	change in area of drusen from baseline to months 12 and 18		12 and 18 months	No
Secondary	change in retinal thickness from baseline to months 12 and 18 measured by OCT		12 and 18 months	No
Secondary	and change in quality of life between baseline and months 12 and 18 using NEI-VFQ25.		12 and 18 months	No

External Links

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